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HeLP (A Healthy Lifestyle program for Pain) for older people with musculoskeletal conditions and comorbid chronic disease risks

HeLP (A Healthy Lifestyle program for Pain) for older people with musculoskeletal conditions and comorbid chronic disease risks

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001086550
Acronym
HeLP for Older People
Enrollment
180
Registered
2024-09-09
Start date
2025-02-26
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Thousands of older Australians with hip, knee and low back pain are referred for surgical consultation, wait extended periods without alternative evidence-based care, and 75% have three or more chronic disease risks (e.g., overweight, smoker). We previously found a Healthy Lifestyle program for Pain (HeLP) reduced disability and improved quality of life. Now we seek to test the best method to scale up the program. We will test if the telehealth delivery of HeLP is as effective as face-to-face delivery on a range of patient-reported measures in older people with long-standing hip, knee and lower back pain. We expect to find similar results between groups.

Interventions

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 we

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.

Sponsors

Hunter New England Local Health District Population Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

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).

Exclusion criteria

- Previous bariatric weight loss surgery - Currently undertaking weight loss or smoking cessation programme or care (e.g., dietetics for weight loss, weight loss medications, Jenny Craig, Lite n’ Easy, Optifast, Weight Watchers, nicotine replacement therapy, Quitline) IF the person has no other chronic disease risk factors. If the patient is currently undertaking a weight loss or smoking cessation program but has another chronic disease risk factor not related to their program they will be eligible for inclusion. Described below: o Currently participating in smoking cessation program- eligible for inclusion if they also have a chronic disease risk for BMI, nutrition, alcohol, or physical activity. o Currently participating in weight loss program- eligible for participation if they also have a chronic disease risk for smoking, alcohol, or physical activity. - 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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026