Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001118998
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
29/10/2020
Date last updated
29/09/2022
Date data sharing statement initially provided
29/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Get Healthy Coaching Service to optimise discharge care for low
back pain in older people: a pilot study
Scientific title
The Get Healthy Coaching Service to optimise discharge care for low
back pain in older people: a pilot study
Secondary ID [1] 302109 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 318736 0
Condition category
Condition code
Musculoskeletal 316751 316751 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual-Only Group – Patients will have a phone session with a member of the study team, who will explain the intervention and register them with the Get Healthy Service (GHS). Following registration participants will then receive up to 13 confidential coaching sessions over 6 months which will be provided on a tapered schedule with coaches from the GHS. All sessions will be delivered via phone with a primary aim to increase physical activity levels, but participants may decide with their coaches to have other health-related goals (i.e. diet, alcohol consumption related goals) if they wish. Participants will decide with the coaches their goals and the time and dates of the sessions that best suit them. The coaches will not influence the choice of the participants and they may choose any physical activity goal they want, which may be to go for a walk once a week for 30 minutes, go for a swim twice per week for 40 minutes, etc. The coaching sessions will be provided by allied health care professionals (such as dietitians or exercise physiologists) who have been trained in health coaching. The anticipated duration of the sessions is of approximately 20 minutes. Attendance at the sessions will be recorded by the health coaches. Physical activities, individual and combined goals and their achievement will be recorded via weekly online diaries and monitored by the health coach during the coaching sessions. The health coach will be there to provide health information, assistance with goal setting and help maintaining motivation.
Buddy-Assisted Group – Patients and their exercise buddies will have a first phone session with a member of the study team, who will explain how the intervention will be delivered, how to maximise the power of the buddies, how each partner can have a positive effect on each other’s behaviour, decide on their combined goal and discuss how they can track their combined goal. The anticipated duration of this session is of approximately 20-30 minutes. Then only the patient (not the buddy) will be registered in the GHS system and will receive up to 13 confidential coaching sessions over 6 months being provided on a tapered schedule with coaches of the GHS. As for the Individual-Only Group, coaches will be nurses and allied health professionals who have been trained in health coaching. The participant and buddy will exercise together at least once per week for 30 minutes. Examples of their combined exercise might be to go for a walk together for 30 minutes once per week, or go bowling together once a week for 30 minutes, etc.
Intervention code [1] 318411 0
Treatment: Other
Intervention code [2] 318443 0
Lifestyle
Comparator / control treatment
Control Group – participants will continue with their discharge care. This discharge care might consist of education, exercise or physical activity prescription or medication and will vary according to the care provided by the treating health care professional. The duration of the discharge care will also vary according to what will be provided by the treating health care professional. However, the usual practice is to provide exercise and education tailored to the patient’s needs with advice to contact the health professional as necessary.
Control group
Active

Outcomes
Primary outcome [1] 324879 0
Number of daily steps
Number of daily steps will be assessed objectively via a worn tri-axial accelerometer (Axivity AX3) for 7 days. The mean daily total volume of physical activity will be considered for analysis.
Timepoint [1] 324879 0
Baseline and at 3 and 6 months post-randomisation
Secondary outcome [1] 386078 0
Sedentary behaviour
It will be assessed via a worn tri-axial accelerometer (Axivity AX3) for 7 days. The mean daily total time in sedentary behaviour (i.e., sitting, standing, laying) will be considered for analysis.
Timepoint [1] 386078 0
Baseline and at 3 and 6 months post-randomisation
Secondary outcome [2] 386079 0
Average pain in the previous week
It will be assessed using 0-100 numerical rating scale.
Timepoint [2] 386079 0
Baseline and at 3 and 6 months post-randomisation
Secondary outcome [3] 386080 0
Disability
It will be assessed with the Roland Morris questionnaire (0-24 scale).
Timepoint [3] 386080 0
Baseline and at 3 and 6 months post-randomisation
Secondary outcome [4] 386083 0
Medicine consumption through paper-based or online diaries to be completed by participants weekly
Timepoint [4] 386083 0
Baseline and weekly until 6 months post-randomisation
Secondary outcome [5] 386084 0
Goal achievement
Participants will be asked to complete a diary with information to track their goals.
Timepoint [5] 386084 0
Baseline and weekly until 6 months post-randomisation
Secondary outcome [6] 387221 0
Visits to allied health professionals or alternative/ natural therapists through paper-based or online diaries to be completed by participants weekly
Timepoint [6] 387221 0
Baseline and weekly until 6 months post-randomisation
Secondary outcome [7] 387222 0
Visitis or admissions to hospitals through paper-based or online diaries to be completed by participants weekly
Timepoint [7] 387222 0
Baseline and weekly until 6-months post-randomisation
Secondary outcome [8] 387223 0
Recruitment rate
It will be defined by the proportion of patients who are screened and eligible and consent to participate in the study. Recruitment rate will be defined as feasible if it is over 70%.
Timepoint [8] 387223 0
Data will be collected during recruitment and will be analysed when recruitment is finished.
Secondary outcome [9] 387224 0
Data collection rate
It will be defined by the proportion of data collection that is completed. It will be considered feasible if there is less than or equal to 20% missing data for outcome measures.
Timepoint [9] 387224 0
It will be collected during the study and will be analysed when the participation of the last patient is finished.
Secondary outcome [10] 387225 0
Follow-up rate
It will be defined by the proportion of participants who complete their follow-up assessments. Follow-up rates will be considered feasible if there is greater than or equal to 85% follow-up rate in both 3 and 6 months assessments.
Timepoint [10] 387225 0
3 and 6 months post-randomisation
Secondary outcome [11] 387226 0
Reach of the intervention
The potential “reach” of the intervention will be analysed by the total number of included participants divided by the total number of potential participants (i.e., patients with potential to be included in the trial that were approached by the study team)
Timepoint [11] 387226 0
Baseline
Secondary outcome [12] 387227 0
Acceptability of the intervention
It will be assessed by a feedback survey designed specifically for this study with opened and closed-ended questions (Likert scale)
Timepoint [12] 387227 0
6 months post-randomisation
Secondary outcome [13] 387228 0
Referring practitioners feedback
It will be assessed with a feedback survey designed specifically for this study with opened and closed-ended questions (Likert scale)
Timepoint [13] 387228 0
Within two months after data collection is finalised

Eligibility
Key inclusion criteria
• Be over the age of 50 years and having been recently discharged from treatment for non-specific low back pain (LBP)
• Have non-specific LBP for at least 3 months and greater than or equal to 2/10 in average pain intensity on the 11-point numeric rating scale for the past week
• Be engaged in less than 300 minutes of total volume of light and moderate physical activity per week
• To have an exercise-buddy willing to exercise together at least once per week for 30 minutes or more
• To have adequate hearing and eyesight and independent ambulatory status
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have specific spinal conditions using the recommended criteria from the clinical practice guideline by the American College of Physicians and the American Pain Society
• Participate in any vigorous sport activities (such as jogging, competitive tennis, vigorous swimming, etc)
• Have had any spinal, hip or knee surgery within last 12 months
• Have had recent corticosteroid injections in the spine (in the past 4 weeks)
• Have evidence of radiculopathy and nerve root compromise (2 out of 3 positive tests for myotome, dermatomes, reflexes)
• Have lumbar neurogenic claudication (i.e. pain, numbness and/or fatigue in the legs that is worse in standing or walking and alleviated during flexion/sitting, or being told by a doctor they have it)
• Have LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation
• Have any comorbid condition that would prevent active participation in performing exercises at home or increasing physical activity levels – any heart or vascular conditions that would prevent the individual from exercising – told by a doctor
• Have any known disease and/or signs or symptoms assessed with the Adult Pre-Exercise Screening System that represent higher risk of having an adverse event due to exercise (i.e. an unexpected event that occurs as a consequence of an exercise session, resulting in ill health, physical harm or death to an individual)
• Have a diagnosis of fibromyalgia or a systematic arthritic condition
• Have cognitive impairment, assessed by the Physiotherapist as being unable to follow instructions and understand the consent form
• History of unexpected falls in the previous 12 months, defined as “an unexpected loss of balance resulting in coming to rest on the floor, the ground, or an object below the knee level"

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)
A researcher concealed from the main assessor of the study will randomise participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The recruitment rate will be analysed by the proportion of people who were screened as eligible participants and consented to participate in the RCT. Data completeness will be assessed by calculating the percentage of missing data completion of clinical outcomes. . Follow-up rate will be defined by the proportion of participants who completed at least one outcome measure. The number of self-reported attendance to the health coaching sessions and their perceived helpfulness will be summarised per randomised arm as central tendency (mean) and variability (SD). The mean and SD per intervention arm for each clinical outcome measure will be calculated. In alignment with the original RCT protocol, the between-group differences in the clinical outcome measures will be explored with linear mixed models.

The feedback surveys were analysed in two ways. The percentage of both Likert-scale, as well as multiple choices answers, were calculated. Additionally, the number of participants choosing the Likert-scale and multiple-choice options was also calculated. Answers to the open-ended question were analysed based on independent thematic data-driven coding by two researchers and were triangulated between researchers for discrepancies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
22/12/2021
Actual
9/12/2021
Date of last data collection
Anticipated
22/06/2022
Actual
22/07/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 306534 0
Government body
Name [1] 306534 0
Sydney Local Health District Allied Health Small Grant
Country [1] 306534 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Concord Repatriation General Hospital
Hospital Rd. Concord 2139
Sydney, NSW
Country
Australia
Secondary sponsor category [1] 307063 0
None
Name [1] 307063 0
NA
Address [1] 307063 0
NA
Country [1] 307063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306730 0
Sydney Local Health District Ethics Committee
Ethics committee address [1] 306730 0
Ethics committee country [1] 306730 0
Australia
Date submitted for ethics approval [1] 306730 0
Approval date [1] 306730 0
19/02/2020
Ethics approval number [1] 306730 0

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

Contacts
Principal investigator
Name 104822 0
Dr Mark Halliday
Address 104822 0
Physiotherapy Outpatient Department
Concord Repatriation General Hospital
Hospital Rd. Concord
NSW 2139
Country 104822 0
Australia
Phone 104822 0
+61 02 97676101
Fax 104822 0
Email 104822 0
[email protected]
Contact person for public queries
Name 104823 0
Mark Halliday
Address 104823 0
Physiotherapy Outpatient Department
Concord Repatriation General Hospital
Hospital Rd. Concord
NSW 2139
Country 104823 0
Australia
Phone 104823 0
+61 02 97676101
Fax 104823 0
Email 104823 0
[email protected]
Contact person for scientific queries
Name 104824 0
Mark Halliday
Address 104824 0
Physiotherapy Outpatient Department
Concord Repatriation General Hospital
Hospital Rd. Concord
NSW 2139
Country 104824 0
Australia
Phone 104824 0
+61 02 97676101
Fax 104824 0
Email 104824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8948Informed consent form  [email protected]
9263Study protocol  [email protected]



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.