Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001508369
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
26/10/2017
Date last updated
25/08/2022
Date data sharing statement initially provided
27/02/2019
Date results information initially provided
1/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Health eLiteracy for Prevention in General Practice


Scientific title
Preventing chronic disease in patients with low health literacy using eHealth and teamwork in primary health care
Secondary ID [1] 292692 0
NHMRC Project Grant APP 1125681
Universal Trial Number (UTN)
U1111-1201-0676
Trial acronym
HeLP-GP
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Obesity 304455 0
Low health literacy 305002 0
Chronic disease 305003 0
Condition category
Condition code
Diet and Nutrition 303788 303788 0 0
Obesity
Public Health 304324 304324 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of:
1. Three training modules of approximately 3 hours duration. These will be offered on an on-line platform (Smart Sparrow) which is an interactive eLearning courseware used at the University of NSW. Both GPs and practice nurses will access these modules in their own time. These will focus on the principles of health literacy and clinical weight management. The modules will also overview study protocols and processes including patient enrolment , the process for conducting health assessments, registering patients with the lifestyle app (My SNAPP), and procedures to ensure patients are followed up and referred to Get Healthy telephone counselling.
2. A medical record audit of practice data performed using Doctors Control Panel (DCP) software. We will use a de-identified audit to illustrate the completeness of practice recording of risk factors and the same variables will be collected on eligible, consenting patients at baseline, 12 months and 18 months. This will be managed by the Field Research Officer (FRO) .
3. Three practice facilitation visits will be provided by a trained facilitator from a local Primary Health Network (PHN). Each face to face visit will be of 1-1.5hrs duration and provided at intervals during the 6-month intervention period. The aim of the practice facilitation is to support general practices in the intervention arm of the HeLP trial to implement effective preventive care which is tailored to the needs of, and develops the knowledge and skills of overweight patients with low health literacy. Facilitators will receive training on the delivery of the sessions and will document these using a facilitator diary.
4. A health check visit for eligible and consenting patients will be undertaken within 4 weeks of recruitment performed by the Practice Nurse. This will utilise the 5As framework (assess, advise, agree, assist and arrange) and cover the following:
Assess - Review baseline BMI, waist circumference, diet and physical activity, cardiovascular and diabetes risk, language and health literacy.
Advise/ Agree - Provide brief advice using video vignettes; check patient understanding using teach-back method; download and log into My SNAPP (an app developed for the trial available on smart phone and tablet); work with each patient to register for the app, set up their profile and instruct them on the use of the app.
Assist - Introduce the Get Healthy telephone coaching program to the patient, (outline purpose of the program and details about participation). If the patient wants to participate, ‘assisted referral’ is made to the program in the presence of the patient. Get Healthy will provide tailored patient lifestyle coaching over 10 one-hour sessions. Coaches are trained by Get Healthy to deliver coaching sessions.
Arrange - Arrange follow up communication and a second visit with the practice nurse at 6 weeks and with the GP at 12 weeks. A 12 month review will be provided by the GP.

Fidelity of the intervention will be assessed by the following measures:
• % of intervention patients who receive health check at baseline, 6 week reviews by the practice nurse and 12 week review by the GP
• Usage of My SNAPP determined by Healthy.me captured analytics (% of patients with documented goals related to lifestyle change; usage data including number of times app accessed; number of pages accessed)
• % who received ‘assisted referral to the Get Healthy telephone counselling service (English speaking/Arabic speaking)
• % of patients who take up (one or more sessions) of the Get Healthy telephone coaching program (English speaking/Arabic speaking)
• % of patients who complete the Get Healthy program (English speaking/Arabic speaking). Completion is defined as completing six of the 10 allocated sessions)
Intervention code [1] 298936 0
Prevention
Intervention code [2] 298937 0
Lifestyle
Intervention code [3] 299311 0
Treatment: Other
Comparator / control treatment
Practices allocated to the control group will provide Usual Care. For the purpose of this study usual care refers to the clinical practice routinely offered to patients by the general practitioner and the practice nurse.
Control group
Active

Outcomes
Primary outcome [1] 303149 0
Health literacy

Health literacy assessed using the Health Literacy Questionaire (HLQ) delivered by a researcher using a telephone interview. We will assess changes between baseline, 6 and 12 months compared by group on individual validated questions from this questionnaire
Timepoint [1] 303149 0
Baseline,
6 months,
12 months
Primary outcome [2] 303150 0
eHealth literacy

eHealth literacy assessed using the e Health Literacy Scale (eHeals) delivered by a researcher using a telephone interview. The eHEALS is an 8-item measure of eHealth literacy developed to measure consumers’ combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems.
Timepoint [2] 303150 0
Baseline 6 months and 12 months
Primary outcome [3] 303151 0
Biomedical risk factors (weight, waist circumference, BMI, blood pressure) assessed through audit of clinical records
Timepoint [3] 303151 0
Baseline 6 months and 12 months
Secondary outcome [1] 338044 0
Behavioural risk factors (Daily fruit and vegetable consumption) assessed from self-reported information via telephone survey
Timepoint [1] 338044 0
Baseline
6 months
Secondary outcome [2] 338045 0
Behavioural risk factors (physical activity level) assessed from self-reported information via telephone survey
Timepoint [2] 338045 0
Baseline
6 months
Secondary outcome [3] 338046 0
Total cholesterol
Timepoint [3] 338046 0
Baseline
12 months
Secondary outcome [4] 338047 0
Health related Quality of Life (QoL) measured by the EQ-5D-5L - data collected from a telephone survey administered by a researcher.
Timepoint [4] 338047 0
Baseline
12 months
Secondary outcome [5] 339507 0
Cost of the intervention. We will use MBS and PBS data and public hospital data from the State Health Departments to assess the cost of the intervention. The MBS, PBS and State data will capture most primary care costs. Non-charged PN visits will be assigned an hourly rate based on PN salary levels plus on-costs. Questions on patient costs in accessing lifestyle services and programs, and non-Medicare funded allied health will be included in the patient questionnaire. Cost estimates will be generated for referrals to community based programs. In the base case analysis, undertaken from a health service perspective, referrals to allied health professionals will only be costed if supported by a Medicare claim. The incremental costs of the intervention, will be presented alongside the consequences with respect to changes in quality of life (in the form of QALY gains informed by the EQ5D-5L) and differences in health literacy, behavioural outcomes, and clinical measures (BMI, blood pressure and Lipids). Deterministic and bootstrapped sensitivity analyses will be undertaken to identify key uncertain parameters and represent uncertainty around the mean estimates, respectively.
Timepoint [5] 339507 0
12 months
Secondary outcome [6] 339641 0
Receipt of advice on smoking. Self reported via a telephone survey
Timepoint [6] 339641 0
Baseline
6 months
Secondary outcome [7] 339642 0
Receipt of advice on diet. Self reported via a telephone survey
Timepoint [7] 339642 0
Baseline
6 months
Secondary outcome [8] 339643 0
Receipt of advice on physical activity Self reported via a telephone survey
Timepoint [8] 339643 0
Baseline
6 months
Secondary outcome [9] 339644 0
Receipt of advice on weight management Self reported via a telephone survey
Timepoint [9] 339644 0
Baseline
6 months

Eligibility
Key inclusion criteria
Situated in Local Government Areas (LGAs) with a SEIFA score equal to or below the 8th decile
• Using Medical Director PracSoft or Best Practice software and allocate patients to individual GPs within this software
• Agree to the use of Doctors Control Panel (DCP) linked with their software to identify eligible patients for the study
• Have access to an active internet connection
• Have at least one practice nurse who is prepared to conduct the HeLP intervention with eligible patients and complete data management relating to these patients
• Agree to provide GP follow up health checks to participating patients at 12 weeks and 12 month time points
• Can make their reception staff available to distribute study materials to potential study participants as they present to the practice

Patients:
• Aged 40-74 years and living in postcodes of interest
• Overweight or obese (BMI=/> 28 recorded in last 12 months)
• Speaking English/Arabic/Chinese/Vietnamese
• With BP recorded in the clinical software within the previous 12 months
• With access to a smart phone or tablet device
• No diagnosis of serious mental illness
Minimum age
40 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Practices:
Unwilling or unable to make the commitment to undertake the study tasks

Patients:
• Experiencing recent weight loss (>5% in past 3mths)
• Cognitive impairment (assessed by clinicians)
• Physical impairment prohibiting the patient from undertaking moderate level physical activity
A diagnosis of Diabetes requiring insulin
• A diagnosis of Cardiovascular disease
• Taking medication for weight loss

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible practices will centrally randomised using a external internet based randomisation service (randomize.net)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified according to State (NSW/SA) and size of practice (under 5 GPs and 5+GPs)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will examine change in outcomes between intervention and control practices, after adjusting for baseline differences. Analyses will be on an Intention-to-Treat (ITT) basis. We will analyse patient variables (health literacy, e-health literacy, risk behaviour, health service use, BP, total cholesterol,quality of life) for within and between practice differences using multilevel linear and logistic regression techniques that adjust for clustering by practice and multiple imputation for missing values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2018
Actual
1/10/2018
Date of last participant enrolment
Anticipated
1/10/2019
Actual
20/01/2020
Date of last data collection
Anticipated
30/04/2021
Actual
7/01/2021
Sample size
Target
1600
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 16984 0
2200 - Bankstown
Recruitment postcode(s) [2] 16985 0
2165 - Fairfield
Recruitment postcode(s) [3] 16986 0
2560 - Campbelltown
Recruitment postcode(s) [4] 16987 0
2193 - Canterbury
Recruitment postcode(s) [5] 16989 0
5108 - Salisbury
Recruitment postcode(s) [6] 16994 0
5015 - Port Adelaide
Recruitment postcode(s) [7] 16995 0
5085 - Enfield
Recruitment postcode(s) [8] 16996 0
5112 - Elizabeth
Recruitment postcode(s) [9] 16999 0
2133 - Croydon Park
Recruitment postcode(s) [10] 17000 0
2193 - Ashbury
Recruitment postcode(s) [11] 17001 0
2194 - Campsie
Recruitment postcode(s) [12] 17002 0
2191 - Belfield
Recruitment postcode(s) [13] 17003 0
2206 - Clemton Park
Recruitment postcode(s) [14] 17004 0
2193 - Hurlstone Park
Recruitment postcode(s) [15] 17005 0
2206 - Earlwood
Recruitment postcode(s) [16] 17006 0
2176 - Abbotsbury
Recruitment postcode(s) [17] 17007 0
2177 - Bonnyrigg
Recruitment postcode(s) [18] 17008 0
2177 - Bonnyrigg Heights
Recruitment postcode(s) [19] 17009 0
2176 - Bossley Park
Recruitment postcode(s) [20] 17010 0
2166 - Cabramatta
Recruitment postcode(s) [21] 17011 0
2166 - Cabramatta West
Recruitment postcode(s) [22] 17012 0
2166 - Canley Heights
Recruitment postcode(s) [23] 17013 0
2166 - Canley Vale
Recruitment postcode(s) [24] 17014 0
2163 - Carramar
Recruitment postcode(s) [25] 17015 0
2178 - Cecil Park
Recruitment postcode(s) [26] 17016 0
2176 - Edensor Park
Recruitment postcode(s) [27] 17017 0
2165 - Fairfield East
Recruitment postcode(s) [28] 17018 0
2165 - Fairfield Heights
Recruitment postcode(s) [29] 17019 0
2165 - Fairfield West
Recruitment postcode(s) [30] 17020 0
2176 - Greenfield Park
Recruitment postcode(s) [31] 17021 0
2161 - Guildford
Recruitment postcode(s) [32] 17022 0
2175 - Horsley Park
Recruitment postcode(s) [33] 17023 0
2166 - Lansvale
Recruitment postcode(s) [34] 17024 0
2170 - Mount Pritchard
Recruitment postcode(s) [35] 17025 0
2161 - Old Guildford
Recruitment postcode(s) [36] 17026 0
2176 - Prairiewood
Recruitment postcode(s) [37] 17027 0
2164 - Smithfield
Recruitment postcode(s) [38] 17028 0
2176 - St Johns Park
Recruitment postcode(s) [39] 17029 0
2163 - Villawood
Recruitment postcode(s) [40] 17030 0
2176 - Wakeley
Recruitment postcode(s) [41] 17031 0
2164 - Wetherill Park
Recruitment postcode(s) [42] 17032 0
2161 - Yennora
Recruitment postcode(s) [43] 17033 0
2200 - Bankstown Aerodrome
Recruitment postcode(s) [44] 17034 0
2200 - Bankstown North
Recruitment postcode(s) [45] 17035 0
2200 - Bankstown Square
Recruitment postcode(s) [46] 17036 0
2197 - Bass Hill
Recruitment postcode(s) [47] 17037 0
2143 - Birrong
Recruitment postcode(s) [48] 17038 0
2162 - Chester Hill
Recruitment postcode(s) [49] 17039 0
2190 - Chullora
Recruitment postcode(s) [50] 17040 0
2200 - Condell Park
Recruitment postcode(s) [51] 17041 0
2213 - East Hills
Recruitment postcode(s) [52] 17042 0
2198 - Georges Hall
Recruitment postcode(s) [53] 17043 0
2190 - Greenacre
Recruitment postcode(s) [54] 17044 0
2163 - Lansdowne
Recruitment postcode(s) [55] 17045 0
2200 - Manahan
Recruitment postcode(s) [56] 17046 0
2214 - Milperra
Recruitment postcode(s) [57] 17047 0
2190 - Mount Lewis
Recruitment postcode(s) [58] 17048 0
2211 - Padstow
Recruitment postcode(s) [59] 17049 0
2211 - Padstow Heights
Recruitment postcode(s) [60] 17050 0
2213 - Panania
Recruitment postcode(s) [61] 17051 0
2213 - Picnic Point
Recruitment postcode(s) [62] 17052 0
2143 - Potts Hill
Recruitment postcode(s) [63] 17053 0
2196 - Punchbowl
Recruitment postcode(s) [64] 17054 0
2143 - Regents Park
Recruitment postcode(s) [65] 17055 0
2212 - Revesby
Recruitment postcode(s) [66] 17056 0
2212 - Revesby Heights
Recruitment postcode(s) [67] 17057 0
2212 - Revesby North
Recruitment postcode(s) [68] 17058 0
2162 - Sefton
Recruitment postcode(s) [69] 17059 0
2135 - Strathfield
Recruitment postcode(s) [70] 17060 0
2136 - Strathfield South
Recruitment postcode(s) [71] 17061 0
2199 - Yagoona
Recruitment postcode(s) [72] 17062 0
2199 - Yagoona West
Recruitment postcode(s) [73] 17063 0
2560 - Airds
Recruitment postcode(s) [74] 17064 0
2560 - Ambarvale
Recruitment postcode(s) [75] 17065 0
2560 - Blair Athol
Recruitment postcode(s) [76] 17066 0
2559 - Blairmount
Recruitment postcode(s) [77] 17067 0
2566 - Bow Bowing
Recruitment postcode(s) [78] 17068 0
2560 - Bradbury
Recruitment postcode(s) [79] 17069 0
2560 - Campbelltown North
Recruitment postcode(s) [80] 17070 0
2559 - Claymore
Recruitment postcode(s) [81] 17071 0
2565 - Denham Court
Recruitment postcode(s) [82] 17072 0
2558 - Eagle Vale
Recruitment postcode(s) [83] 17073 0
2560 - Englorie Park
Recruitment postcode(s) [84] 17074 0
2558 - Eschol Park
Recruitment postcode(s) [85] 17075 0
2560 - Gilead
Recruitment postcode(s) [86] 17156 0
2560 - Glen Alpine
Recruitment postcode(s) [87] 17157 0
2167 - Glenfield
Recruitment postcode(s) [88] 17158 0
2564 - Glenquarie
Recruitment postcode(s) [89] 17159 0
2565 - Ingleburn
Recruitment postcode(s) [90] 17160 0
2174 - Ingleburn Milpo
Recruitment postcode(s) [91] 17161 0
2558 - Kearns
Recruitment postcode(s) [92] 17162 0
2560 - Kentlyn
Recruitment postcode(s) [93] 17163 0
2179 - Leppington
Recruitment postcode(s) [94] 17164 0
2560 - Leumeah
Recruitment postcode(s) [95] 17165 0
2564 - Long Point
Recruitment postcode(s) [96] 17166 0
2565 - Macquarie Links
Recruitment postcode(s) [97] 17167 0
2564 - Macquarie Fields
Recruitment postcode(s) [98] 17168 0
2563 - Menangle Park
Recruitment postcode(s) [99] 17169 0
2566 - Minto
Recruitment postcode(s) [100] 17170 0
2566 - Minto Heights
Recruitment postcode(s) [101] 17171 0
2566 - Raby
Recruitment postcode(s) [102] 17172 0
2560 - Rosemeadow
Recruitment postcode(s) [103] 17173 0
2560 - Ruse
Recruitment postcode(s) [104] 17174 0
2560 - St Helens Park
Recruitment postcode(s) [105] 17175 0
2566 - St Andrews
Recruitment postcode(s) [106] 17176 0
2566 - Varroville
Recruitment postcode(s) [107] 17177 0
2560 - Wedderburn
Recruitment postcode(s) [108] 17178 0
2560 - Woodbine
Recruitment postcode(s) [109] 17179 0
5110 - Waterloo Corner
Recruitment postcode(s) [110] 17180 0
5112 - Elizabeth East
Recruitment postcode(s) [111] 17181 0
5112 - Elizabeth Grove
Recruitment postcode(s) [112] 17182 0
5112 - Elizabeth South
Recruitment postcode(s) [113] 17183 0
5112 - Elizabeth Vale
Recruitment postcode(s) [114] 17184 0
5112 - Hillbank
Recruitment postcode(s) [115] 17185 0
5113 - Davoren Park
Recruitment postcode(s) [116] 17186 0
5113 - Elizabeth Downs
Recruitment postcode(s) [117] 17187 0
5113 - Elizabeth North
Recruitment postcode(s) [118] 17188 0
5113 - Elizabeth Park
Recruitment postcode(s) [119] 17189 0
5113 - Elizabeth West
Recruitment postcode(s) [120] 17190 0
5114 - Andrews Farm
Recruitment postcode(s) [121] 17191 0
5114 - Blakeview
Recruitment postcode(s) [122] 17192 0
5114 - Craigmore
Recruitment postcode(s) [123] 17193 0
5114 - Gould Creek
Recruitment postcode(s) [124] 17194 0
5114 - Humbug Scrub
Recruitment postcode(s) [125] 17195 0
5114 - One Tree Hill
Recruitment postcode(s) [126] 17196 0
5114 - Smithfield
Recruitment postcode(s) [127] 17197 0
5114 - Smithfield Plains
Recruitment postcode(s) [128] 17198 0
5114 - Uleybury
Recruitment postcode(s) [129] 17199 0
5114 - Yattalunga
Recruitment postcode(s) [130] 17200 0
5115 - Munno Para
Recruitment postcode(s) [131] 17201 0
5115 - Munno Para Downs
Recruitment postcode(s) [132] 17202 0
5115 - Munno Para West
Recruitment postcode(s) [133] 17203 0
5116 - Hillier
Recruitment postcode(s) [134] 17204 0
5117 - Angle Vale
Recruitment postcode(s) [135] 17205 0
5118 - Bibaringa
Recruitment postcode(s) [136] 17206 0
5120 - Virginia
Recruitment postcode(s) [137] 17207 0
5121 - Macdonald Park
Recruitment postcode(s) [138] 17208 0
5121 - Penfield
Recruitment postcode(s) [139] 17209 0
5121 - Penfield Gardens
Recruitment postcode(s) [140] 17210 0
5008 - Croydon Park
Recruitment postcode(s) [141] 17211 0
5008 - Devon Park
Recruitment postcode(s) [142] 17212 0
5008 - Dudley Park
Recruitment postcode(s) [143] 17213 0
5010 - Angle Park
Recruitment postcode(s) [144] 17214 0
5010 - Ferryden Park
Recruitment postcode(s) [145] 17215 0
5010 - Regency Park
Recruitment postcode(s) [146] 17216 0
5012 - Mansfield Park
Recruitment postcode(s) [147] 17217 0
5012 - Woodville Gardens
Recruitment postcode(s) [148] 17218 0
5013 - Ottoway
Recruitment postcode(s) [149] 17219 0
5013 - Rosewater
Recruitment postcode(s) [150] 17220 0
5013 - Wingfield
Recruitment postcode(s) [151] 17221 0
5014 - Alberton
Recruitment postcode(s) [152] 17222 0
5014 - Queenstown
Recruitment postcode(s) [153] 17223 0
5015 - Birkenhead
Recruitment postcode(s) [154] 17224 0
5015 - Ethelton
Recruitment postcode(s) [155] 17225 0
5015 - Glanville
Recruitment postcode(s) [156] 17226 0
5015 - New Port
Recruitment postcode(s) [157] 17227 0
5016 - Largs Bay
Recruitment postcode(s) [158] 17228 0
5016 - Largs North
Recruitment postcode(s) [159] 17229 0
5016 - Peterhead
Recruitment postcode(s) [160] 17230 0
5017 - Osborne
Recruitment postcode(s) [161] 17231 0
5017 - Taperoo
Recruitment postcode(s) [162] 17232 0
5018 - North Haven
Recruitment postcode(s) [163] 17233 0
5018 - Outer Harbor
Recruitment postcode(s) [164] 17234 0
5019 - Exeter
Recruitment postcode(s) [165] 17235 0
5019 - Semaphore
Recruitment postcode(s) [166] 17236 0
5019 - Semaphore South
Recruitment postcode(s) [167] 17237 0
5075 - Dernancourt
Recruitment postcode(s) [168] 17240 0
5084 - Blair Athol
Recruitment postcode(s) [169] 17241 0
5084 - Kilburn
Recruitment postcode(s) [170] 17242 0
5085 - Clearview
Recruitment postcode(s) [171] 17243 0
5085 - Northfield
Recruitment postcode(s) [172] 17244 0
5085 - Northgate
Recruitment postcode(s) [173] 17245 0
5086 - Gilles Plains
Recruitment postcode(s) [174] 17246 0
5086 - Greenacres
Recruitment postcode(s) [175] 17247 0
5086 - Hampstead Gardens
Recruitment postcode(s) [176] 17248 0
5086 - Hillcrest
Recruitment postcode(s) [177] 17249 0
5086 - Manningham
Recruitment postcode(s) [178] 17250 0
5086 - Oakden
Recruitment postcode(s) [179] 17251 0
5087 - Klemzig
Recruitment postcode(s) [180] 17252 0
5087 - Windsor Gardens
Recruitment postcode(s) [181] 17253 0
5088 - Holden Hill
Recruitment postcode(s) [182] 17254 0
5093 - Valley View
Recruitment postcode(s) [183] 17255 0
5094 - Dry Creek
Recruitment postcode(s) [184] 17256 0
5094 - Gepps Cross
Recruitment postcode(s) [185] 17257 0
5098 - Walkley Heights
Recruitment postcode(s) [186] 17258 0
5093 - Para Vista
Recruitment postcode(s) [187] 17259 0
5095 - Mawson Lakes
Recruitment postcode(s) [188] 17260 0
5095 - Pooraka
Recruitment postcode(s) [189] 17261 0
5096 - Gulfview Heights
Recruitment postcode(s) [190] 17262 0
5096 - Para Hills
Recruitment postcode(s) [191] 17263 0
5096 - Para Hills West
Recruitment postcode(s) [192] 17264 0
5098 - Ingle Farm
Recruitment postcode(s) [193] 17265 0
5106 - Parafield
Recruitment postcode(s) [194] 17266 0
5106 - Salisbury South
Recruitment postcode(s) [195] 17267 0
5107 - Green Fields
Recruitment postcode(s) [196] 17268 0
5107 - Parafield Gardens
Recruitment postcode(s) [197] 17269 0
5108 - Paralowie
Recruitment postcode(s) [198] 17270 0
5108 - Salisbury Downs
Recruitment postcode(s) [199] 17271 0
5108 - Salisbury North
Recruitment postcode(s) [200] 17272 0
5109 - Brahma Lodge
Recruitment postcode(s) [201] 17273 0
5109 - Salisbury East
Recruitment postcode(s) [202] 17274 0
5109 - Salisbury Heights
Recruitment postcode(s) [203] 17275 0
5109 - Salisbury Park
Recruitment postcode(s) [204] 17276 0
5109 - Salisbury Plain
Recruitment postcode(s) [205] 17277 0
5110 - Bolivar
Recruitment postcode(s) [206] 17278 0
5110 - Burton
Recruitment postcode(s) [207] 17279 0
5110 - Globe Derby Park
Recruitment postcode(s) [208] 17280 0
5111 - Edinburgh
Recruitment postcode(s) [209] 17288 0
2560 - Macarthur Square
Recruitment postcode(s) [210] 17290 0
5120 - Buckland Park
Recruitment postcode(s) [211] 17694 0
2168 - Ashcroft
Recruitment postcode(s) [212] 17695 0
2179 - Austral
Recruitment postcode(s) [213] 17696 0
2555 - Badgerys Creek
Recruitment postcode(s) [214] 17697 0
2556 - Bringelly
Recruitment postcode(s) [215] 17698 0
2168 - Busby
Recruitment postcode(s) [216] 17699 0
2171 - Carnes Hill
Recruitment postcode(s) [217] 17700 0
2168 - Cartwright
Recruitment postcode(s) [218] 17701 0
2170 - Casula Mall
Recruitment postcode(s) [219] 17702 0
2171 - Cecil Hills
Recruitment postcode(s) [220] 17703 0
2170 - Chipping Norton
Recruitment postcode(s) [221] 17704 0
2174 - Edmondson Park
Recruitment postcode(s) [222] 17705 0
2168 - Green Valley
Recruitment postcode(s) [223] 17706 0
2745 - Greendale
Recruitment postcode(s) [224] 17707 0
2170 - Hammondville
Recruitment postcode(s) [225] 17708 0
2168 - Heckenberg
Recruitment postcode(s) [226] 17709 0
2168 - Hinchinbrook
Recruitment postcode(s) [227] 17710 0
2173 - Holsworthy
Recruitment postcode(s) [228] 17711 0
2171 - Horningsea Park
Recruitment postcode(s) [229] 17712 0
2171 - Hoxton Park
Recruitment postcode(s) [230] 17714 0
2178 - Kemps Creek
Recruitment postcode(s) [231] 17715 0
2170 - Liverpool
Recruitment postcode(s) [232] 17716 0
2170 - Liverpool South
Recruitment postcode(s) [233] 17717 0
2170 - Liverpool Westfield
Recruitment postcode(s) [234] 17718 0
2745 - Luddenham
Recruitment postcode(s) [235] 17719 0
2170 - Lurnea
Recruitment postcode(s) [236] 17720 0
2168 - Miller
Recruitment postcode(s) [237] 17721 0
2170 - Moorebank
Recruitment postcode(s) [238] 17722 0
2172 - Pleasure Point
Recruitment postcode(s) [239] 17723 0
2170 - Prestons
Recruitment postcode(s) [240] 17724 0
2557 - Rossmore
Recruitment postcode(s) [241] 17725 0
2168 - Sadleir
Recruitment postcode(s) [242] 17726 0
2170 - Warwick Farm
Recruitment postcode(s) [243] 17727 0
2172 - Voyager Point
Recruitment postcode(s) [244] 17728 0
2745 - Wallacia
Recruitment postcode(s) [245] 17729 0
2173 - Wattle Grove
Recruitment postcode(s) [246] 17730 0
2171 - West Hoxton
Recruitment postcode(s) [247] 17731 0
2170 - Casula
Recruitment postcode(s) [248] 17732 0
2171 - Middleton Grange
Recruitment postcode(s) [249] 17733 0
2850 - Cross Roads
Recruitment postcode(s) [250] 17734 0
5047 - Darlington
Recruitment postcode(s) [251] 17735 0
5051 - Coromandel Valley
Recruitment postcode(s) [252] 17736 0
5153 - Ironbank
Recruitment postcode(s) [253] 17737 0
5157 - Cherry Gardens
Recruitment postcode(s) [254] 17738 0
5157 - Clarendon
Recruitment postcode(s) [255] 17739 0
5157 - Coromandel East
Recruitment postcode(s) [256] 17740 0
5157 - Kangarilla
Recruitment postcode(s) [257] 17741 0
5158 - O'halloran Hill
Recruitment postcode(s) [258] 17742 0
5159 - Aberfoyle Park
Recruitment postcode(s) [259] 17743 0
5159 - Chandlers Hill
Recruitment postcode(s) [260] 17744 0
5159 - Flagstaff Hill
Recruitment postcode(s) [261] 17745 0
5159 - Happy Valley
Recruitment postcode(s) [262] 17746 0
5160 - Lonsdale
Recruitment postcode(s) [263] 17747 0
5161 - Old Reynella
Recruitment postcode(s) [264] 17748 0
5161 - Reynella
Recruitment postcode(s) [265] 17749 0
5161 - Reynella East
Recruitment postcode(s) [266] 17750 0
5162 - Morphett Vale
Recruitment postcode(s) [267] 17751 0
5162 - Woodcroft
Recruitment postcode(s) [268] 17752 0
5163 - Hackham
Recruitment postcode(s) [269] 17753 0
5163 - Hackham West
Recruitment postcode(s) [270] 17754 0
5163 - Huntfield Heights
Recruitment postcode(s) [271] 17755 0
5164 - Christie Downs
Recruitment postcode(s) [272] 17756 0
5165 - Christies Beach
Recruitment postcode(s) [273] 17757 0
5166 - O'sullivan Beach
Recruitment postcode(s) [274] 17758 0
5167 - Port Noarlunga
Recruitment postcode(s) [275] 17759 0
5167 - Port Noarlunga South
Recruitment postcode(s) [276] 17760 0
5168 - Noarlunga Centre
Recruitment postcode(s) [277] 17761 0
5168 - Noarlunga Downs
Recruitment postcode(s) [278] 17762 0
5168 - Old Noarlunga
Recruitment postcode(s) [279] 17763 0
5169 - Moana
Recruitment postcode(s) [280] 17764 0
5169 - Seaford
Recruitment postcode(s) [281] 17765 0
5169 - Seaford Meadows
Recruitment postcode(s) [282] 17766 0
5169 - Seaford Rise
Recruitment postcode(s) [283] 17767 0
5170 - Maslin Beach
Recruitment postcode(s) [284] 17768 0
5171 - Blewitt Springs
Recruitment postcode(s) [285] 17769 0
5171 - Mclaren Flat
Recruitment postcode(s) [286] 17770 0
5171 - Mclaren Vale
Recruitment postcode(s) [287] 17771 0
5171 - Tatachilla
Recruitment postcode(s) [288] 17772 0
5172 - Whites Valley
Recruitment postcode(s) [289] 17773 0
5172 - Willunga
Recruitment postcode(s) [290] 17774 0
5172 - Willunga South
Recruitment postcode(s) [291] 17775 0
5173 - Aldinga
Recruitment postcode(s) [292] 17776 0
5173 - Aldinga Beach
Recruitment postcode(s) [293] 17777 0
5173 - Port Willunga
Recruitment postcode(s) [294] 17778 0
5174 - Sellicks Beach
Recruitment postcode(s) [295] 17779 0
5174 - Sellicks Hill
Recruitment postcode(s) [296] 17780 0
5007 - Bowden
Recruitment postcode(s) [297] 17781 0
5007 - Brompton
Recruitment postcode(s) [298] 17782 0
5007 - Hindmarsh
Recruitment postcode(s) [299] 17783 0
5007 - Welland
Recruitment postcode(s) [300] 17784 0
5007 - West Hindmarsh
Recruitment postcode(s) [301] 17785 0
5008 - Renown Park
Recruitment postcode(s) [302] 17786 0
5008 - Ridleyton
Recruitment postcode(s) [303] 17787 0
5008 - West Croydon
Recruitment postcode(s) [304] 17788 0
5009 - Allenby Gardens
Recruitment postcode(s) [305] 17789 0
5009 - Beverley
Recruitment postcode(s) [306] 17790 0
5009 - Kilkenny
Recruitment postcode(s) [307] 17791 0
5011 - Woodville
Recruitment postcode(s) [308] 17792 0
5011 - Woodville Park
Recruitment postcode(s) [309] 17793 0
5011 - Woodville South
Recruitment postcode(s) [310] 17794 0
5011 - Woodville West
Recruitment postcode(s) [311] 17795 0
5012 - Athol Park
Recruitment postcode(s) [312] 17805 0
5013 - Pennington
Recruitment postcode(s) [313] 17812 0
5014 - Albert Park

Funding & Sponsors
Funding source category [1] 297334 0
Government body
Name [1] 297334 0
National Health and Medical Research Council (NHMRC)
Country [1] 297334 0
Australia
Primary sponsor type
University
Name
The University of NSW
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 296307 0
None
Name [1] 296307 0
Address [1] 296307 0
Country [1] 296307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298435 0
University of NSW HREC
Ethics committee address [1] 298435 0
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Ethics committee country [1] 298435 0
Australia
Date submitted for ethics approval [1] 298435 0
31/05/2017
Approval date [1] 298435 0
27/07/2017
Ethics approval number [1] 298435 0
HC17474

Summary
Brief summary
Being overweight or obese increases the chance of a person developing chronic conditions such as diabetes and heart disease. This study aims to help these people find and use relevant health information to improve their diet, increase the amount of physical activity they do, and generally improve their health, thereby preventing the development of chronic disease.

We are conducting this study in general practice because most Australians routinely visit their general practitioner (GP). We will be supporting GPs and practice nurses (PNs) to provide a smart phone/tablett app (SNAPP) that will allow each person to monitor aspects of their health like their weight, blood pressure and cholesterol and to track changes in these over time. Each person will receive individualised information, advice and support that will help them to set some achievable goals around lifestyle change. Each person will also be offered ten sessions of confidential telephone based counseling over a three month period. Nurses will guide this process and make assisted referrals for patients so they can access the help they want.

Our research has shown a need for this type of program and previous results suggest that these programs can create lasting health benefits. This study aims to provide a non- judgemental approach and provide the assistance and advice needed to improve motivation, to stay on track and achieve individual goals.

The aim of this study is to evaluate the implementation and effectiveness of a primary care based preventive care intervention. The intervention is tailored to the needs of, and develops the knowledge and skills of overweight or obese patients with low health literacy.

The overarching research question is:
Can an eHealth intervention tailored to low health literacy and targeted at overweight and obese individuals from general practice change:

a) Patients general health literacy and eHealth literacy?
b) Physiological risk factors?
c) Lifestyle behaviours – smoking diet, alcohol and physical activity?
d) The preventive care they receive in general practice from GPs and PNs and their adherence to planned care?

PRIMARY HYPOTHESES:
1. Compared to those attending control general practices, overweight or obese patients who attend intervention practices will, at 6 and 12 months:
a) Increase health literacy related to preventive care by 10% at 6 and 12 months
b) Increased self-reported physical activity and daily fruit and vegetable intake by 10% at 6 and 12 months
c) Decrease physiological risk factors by 7%: weight, blood pressure, at 12 months
These changes will be greater for intervention group patients with lower than those with higher health literacy.
Trial website
NA
Trial related presentations / publications
NA
Public notes
This is a cluster randomised controlled trial We aim to recruit 40 practices (20 in each arm) and 1600 patients belonging to those practices (800 each arm). The target numbers refer to patients and not practices. We are targeting 5 LGAs in NSW (Canterbury, Liverpool, Fairfield, Bankstown and Campbelltown) and 5 LGAs in Adelaide (Playford, Port Adelaide/Enfield, Onkaparinga, Charles Sturt and Salisbury).

Contacts
Principal investigator
Name 77078 0
Prof Mark Harris
Address 77078 0
Centre for Primary Health Care and Equity
Level 3 AGSM
University of NSW, Randwick 2052
Australia
Country 77078 0
Australia
Phone 77078 0
+ 61 2 9385 8384
Fax 77078 0
+61 2 93851513
Email 77078 0
[email protected]
Contact person for public queries
Name 77079 0
Ms Sharon Parker
Address 77079 0
Centre for Primary Health Care and Equity
Level 3 AGSM
University of NSW, Randwick 2052
Australia
Country 77079 0
Australia
Phone 77079 0
+ 61 2 9385 8384
Fax 77079 0
+61 2 93851513
Email 77079 0
[email protected]
Contact person for scientific queries
Name 77080 0
Prof Mark Harris
Address 77080 0
Centre for Primary Health Care and Equity
Level 3 AGSM
University of NSW, Randwick 2052
Australia
Country 77080 0
Australia
Phone 77080 0
+ 61 2 9385 8384
Fax 77080 0
+61 2 93851513
Email 77080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Study protocol
Analysis plan
Metadata for all publications
When will data be available (start and end dates)?
For verification of published results: immediately following publication
For new analysis: 12 months after the trial has concluded
Data will be available 5 years from the publication of the main trial outcomes
Available to whom?
Determined at the time of request if approved within Ethics approval and within terms of funding
Available for what types of analyses?
To be determined at the time of proposal (see above)
How or where can data be obtained?
By contacting the Chief Investigator by email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17027Study protocolParker SM, Stocks N, Nutbeam D, et al. Preventing chronic disease in patients with low health literacy using eHealth and teamwork in primary healthcare: protocol for a cluster randomised controlled trial. BMJ Open 2018;8(e023239) doi: 10.1136/bmjopen-2018-023239 [email protected]
17028Ethical approval  [email protected]
17029Other  [email protected] Study reports prepared for the participants in the... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePreventing chronic disease in overweight and obese patients with low health literacy using eHealth and teamwork in primary healthcare (HeLP-GP): A cluster randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-060393
EmbasePreventing chronic disease in patients with low health literacy using eHealth and teamwork in primary healthcare: Protocol for a cluster randomised controlled trial.2018https://dx.doi.org/10.1136/bmjopen-2018-023239
N.B. These documents automatically identified may not have been verified by the study sponsor.