Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001086550
Ethics application status
Approved
Date submitted
14/08/2024
Date registered
9/09/2024
Date last updated
9/09/2024
Date data sharing statement initially provided
9/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
HeLP (A Healthy Lifestyle program for Pain) for older people with musculoskeletal conditions and comorbid chronic disease risks
Scientific title
HeLP (A Healthy Lifestyle program for Pain) for older people with musculoskeletal conditions and comorbid chronic disease risks
Secondary ID [1] 312511 0
None
Universal Trial Number (UTN)
Trial acronym
HeLP for Older People
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 334780 0
Hip pain 334781 0
Knee pain 334782 0
Condition category
Condition code
Musculoskeletal 331343 331343 0 0
Osteoarthritis
Musculoskeletal 331344 331344 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The HeLP model of care is an evidence-based model of care that integrates the management of musculoskeletal conditions, pain education, behaviour change communication and support for chronic disease risk factors (excess weight, smoking, poor nutrition, risky alcohol intake, and physical inactivity), which are known to affect the prognosis of musculoskeletal conditions.
HeLP consists of two key elements, delivered over a six-month period:
i. Consultations with HeLP-trained clinicians over 12 weeks. Consultations are 20 to 60 minutes in duration.
An experienced physiotherapist will conduct a clinical assessment and provide condition specific advice and education, along with formative instructions about the coordinated care intervention. The advice will incorporate international guideline recommended education and reassurance, with explanation of the mechanisms by which weight loss and smoking cessation can improve symptoms and reduce health risks. Specifically, provision of advice aims to improve understanding of self-management principles for musculoskeletal conditions, reinforce the need to stay active or gradually increase activity, and avoid bed rest, along with a clinically delivered rationale for the treatment approaches.
ii. Integration and referral to ‘wrap-around’ health behaviour change support services (e.g., New South Wales ‘Get Healthy Information and Coaching Service’ (GHS) and Quitline).
All patients will be referred to a 3-month telephone-based weight management coaching program delivered by health professionals from the NSW GHS. Each session aims to assist patients to set goals regarding change in diet and physical activity and to overcome barriers to making such changes. All content and advice are provided according to standardised protocols and aligns with national diet and physical activity guidelines. All sessions will be based on self-regulation principles, including self-monitoring, goal setting, cognitive restructuring, problem solving, and environmental management. The sessions will assist patients to set goals, regarding the change in diet and physical activity and overcome barriers to making such changes. Timing of GHS calls will be at the discretion of the participant and the GHS coach.
Participants who smoke or report they have ‘quit’ in the last month, will be referred to the NSW Quitline. Quitline counsellors (advisors) who are trained in health/education/psychology and smoking cessation, will contact participants, and systematically record information on smoking history and previous quit attempts. Advisors encourage smokers to set a quit date, and assist in maximising success of quitting by guiding participants through evidence-based cessation methods with consideration of individual preferences and past history of quitting. Advisors also assist callers to deal with issues such as withdrawal symptoms. After the initial contact, and establishment of a quit date, participants will be phoned regularly throughout their Quit journey. Timing of Quitline calls will be at the discretion of the participant and the Quitline staff.

The primary physiotherapist delivering assessment, advice, and monitoring will act as a coordinated care liaison for the weight management and smoking programs. These strategies are aimed to enhance uptake and adherence.

The intervention for this trial is telehealth delivery.
The components of HeLP will be delivered via telehealth in shorter and more frequent consultations, allowing for a more uniform schedule of support and guidance. The telehealth model will involve 3-6 physiotherapy sessions (Week 1 [40mins], subsequent appointments [20mins]). The timing/frequency of the appointments will be individualised and at the discretion of the treating therapist and the participant; however, all sessions will be completed within the 12-week intervention period. The HeLP clinician will undertake a subjective and objective physiotherapy assessment as needed at each appointment to assist them with tracking achievements and progressing goals. All participants will be referred to appropriate wrap-around services. Advice relating to diet will be provided by the HeLP-trained physiotherapists and the health coaches from the wrap-around services. Telehealth physiotherapists will be provided with training related to nutrition and diet via a 30-minute training session delivered by a dietitian member of the project team. Any participants who require further dietary advice will be offered a referral to a dietitian member of the project team for a 30-minute telehealth consultation. Following the initial consultation, all participants will be posted a HeLP booklet containing goal-setting exercises and pain diaries and includes QR links to educational videos.

A number of strategies will be used to assess/monitor adherence to the intervention (e.g., fidelity checklists completed by HeLP clinicians after each appointment, Get Healthy Service engagement- calls completed and 'graduation' status from program, process evaluation with HeLP clinicians and participants following the trial), see outcomes for further details.
Intervention code [1] 329279 0
Lifestyle
Intervention code [2] 329386 0
Treatment: Other
Comparator / control treatment
The HeLP model of care is an evidence-based model of care that integrates the management of musculoskeletal conditions, pain education, behaviour change communication and support for chronic disease risk factors (excess weight, smoking, poor nutrition, risky alcohol intake, and physical inactivity), which are known to affect the prognosis of musculoskeletal conditions.
HeLP consists of two key elements, delivered over a six-month period:
i. Consultations with HeLP-trained clinicians over 12 weeks. Consultations are 20 to 60 minutes in duration.
An experienced physiotherapist will conduct a clinical assessment and provide condition specific advice and education, along with formative instructions about the coordinated care intervention. The advice will incorporate international guideline recommended education and reassurance, with explanation of the mechanisms by which weight loss and smoking cessation can improve symptoms and reduce health risks. Specifically, provision of advice aims to improve understanding of self-management principles for musculoskeletal conditions, reinforce the need to stay active or gradually increase activity, and avoid bed rest, along with a clinically delivered rationale for the treatment approaches.
ii. Integration and referral to ‘wrap-around’ health behaviour change support services (e.g., New South Wales ‘Get Healthy Information and Coaching Service’ (GHS) and Quitline).
All patients will be referred to a 3-month telephone-based weight management coaching program delivered by health professionals from the NSW GHS. Each session aims to assist patients to set goals regarding change in diet and physical activity and to overcome barriers to making such changes. All content and advice are provided according to standardised protocols and aligns with national diet and physical activity guidelines. All sessions will be based on self-regulation principles, including self-monitoring, goal setting, cognitive restructuring, problem solving, and environmental management. The sessions will assist patients to set goals, regarding the change in diet and physical activity and overcome barriers to making such changes.
Participants who smoke or report they have ‘quit’ in the last month, will be referred to the NSW Quitline. Quitline counsellors (advisors) who are trained in health/education/psychology and smoking cessation, will contact participants, and systematically record information on smoking history and previous quit attempts. Advisors encourage smokers to set a quit date, and assist in maximising success of quitting by guiding participants through evidence-based cessation methods with consideration of individual preferences and past history of quitting. Advisors also assist callers to deal with issues such as withdrawal symptoms. After the initial contact, and establishment of a quit date, participants will be phoned regularly throughout their Quit journey.

The primary physiotherapist delivering assessment, advice, and monitoring will act as a coordinated care liaison for the weight management and smoking programs. These strategies are aimed to enhance uptake and adherence.

The comparator for this trial is face-to-face delivery.
Five clinical consultations (four physiotherapy consultations (Weeks 1 [60mins], 3 [30mins], 6 [30mins], 12 [30mins]), and one dietitian consultation (Week 3 [30mins])) will be delivered face-to-face by public hospital physiotherapists and dietitians, trained in the delivery of HeLP. The face-to-face delivery will be within the hospital outpatient department. At the initial consultation, all participants are provided with a HeLP booklet containing goal-setting exercises and pain diaries and includes QR links to educational videos. Participants will also be referred to the appropriate wrap-around services.
Control group
Active

Outcomes
Primary outcome [1] 339105 0
Pain Impact measure
Timepoint [1] 339105 0
Baseline, 6, 12, 26 weeks post randomisation. 26 weeks is the primary timepoint.
Secondary outcome [1] 438564 0
Weight
Timepoint [1] 438564 0
Week 1 and 12 post-randomisation.
Secondary outcome [2] 438565 0
Weight
Timepoint [2] 438565 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [3] 438566 0
Disability
Timepoint [3] 438566 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [4] 438567 0
Quality of Life
Timepoint [4] 438567 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [5] 438568 0
Pain self-efficacy
Timepoint [5] 438568 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [6] 438569 0
Smoking/Vaping status
Timepoint [6] 438569 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [7] 438570 0
Physical Activity
Timepoint [7] 438570 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [8] 438571 0
Nutrition
Timepoint [8] 438571 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [9] 438572 0
Alcohol consumption
Timepoint [9] 438572 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [10] 438573 0
Falls
Timepoint [10] 438573 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [11] 438574 0
Fear of falling
Timepoint [11] 438574 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [12] 438575 0
Adverse Events (e.g., exacerbation of condition, falls)
Timepoint [12] 438575 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [13] 438576 0
Health Economics
Timepoint [13] 438576 0
Baseline, 6, 12, 26 weeks post randomisation.
Secondary outcome [14] 438579 0
Carbon Footprinting
Timepoint [14] 438579 0
Baseline, 6, 12, 26 weeks post randomisation.

Eligibility
Key inclusion criteria
- Aged 65 years and over, with one of the following chronic musculoskeletal conditions (pain or disability due to osteoarthritis of the knee or hip, or non-specific low back pain) present for more than three months
- Pain intensity over the last week of greater than or equal to 3 on a 11-point numerical rating scale OR respond ‘moderately’, ‘quite a bit’ or ‘extremely’ when asked how much their condition interferes with completing normal daily activities
- At least one chronic disease risk factor: overweight or obese (Body Mass Index [BMI]
greater than 25kg/m2), participate in less than 30mins of physical activity on five days of the week, current smoker or vaper, eat less than two serves of fruits and/or less than five serves of vegetables per day (proxy of overall diet quality), or risky alcohol intake (assessed using AUDIT-C).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous bariatric weight loss surgery
- Currently undertaking weight loss or smoking cessation programme or care (e.g., dietetics for weight loss, Jenny Craig, Lite n’ Easy, Optifast, Weight Watchers, nicotine replacement therapy, Quitline).
- Orthopaedic surgery in the previous 6 months or planned surgery in the next 6 months
- Cannot actively engage in the intervention (e.g., unable to communicate, impaired cognition, use a telehealth service (including telephone) or attend appointments, adapt meals or exercise).
- Comorbidity that does not allow safe completion of study procedures (e.g., uncontrolled blood pressure or heart condition, uncontrolled diabetes or other complex dietary requirements).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary analysis will compare follow-up time-points between groups (primary endpoint 26 weeks post randomisation). We will use generalised mixed regression models with appropriate distribution and link functions to compare differences between groups at follow-up. We will obtain estimates of the effect of the intervention and 95% confidence intervals by constructing linear contrasts to compare the adjusted mean change (continuous variables) or difference in proportions (dichotomous variables) in outcomes from baseline to each time point between the groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316935 0
Charities/Societies/Foundations
Name [1] 316935 0
HCF Research Foundation
Country [1] 316935 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District Population Health
Address
Country
Australia
Secondary sponsor category [1] 319181 0
University
Name [1] 319181 0
University of Sydney
Address [1] 319181 0
Country [1] 319181 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315685 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315685 0
Ethics committee country [1] 315685 0
Australia
Date submitted for ethics approval [1] 315685 0
28/06/2024
Approval date [1] 315685 0
22/07/2024
Ethics approval number [1] 315685 0
2024/ETH01214

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135506 0
Dr Simon Davidson
Address 135506 0
Population Health, Hunter New England Local Health District, Longworth Ave, Wallsend NSW 2287
Country 135506 0
Australia
Phone 135506 0
+61 02 9351 9923
Fax 135506 0
Email 135506 0
[email protected]
Contact person for public queries
Name 135507 0
Simon Davidson
Address 135507 0
Population Health, Hunter New England Local Health District, Longworth Ave, Wallsend NSW 2287
Country 135507 0
Australia
Phone 135507 0
+61 02 9351 9923
Fax 135507 0
Email 135507 0
[email protected]
Contact person for scientific queries
Name 135508 0
Simon Davidson
Address 135508 0
Population Health, Hunter New England Local Health District, Longworth Ave, Wallsend NSW 2287
Country 135508 0
Australia
Phone 135508 0
+61 02 9351 9923
Fax 135508 0
Email 135508 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?
De-identified individual participant data collected during the trial
When will data be available (start and end dates)?
Start- Immediately following publication
End- 5 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal that is approved by the Principal Investigator ([email protected])
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.