Comparison of In-person and Virtual Delivery of Healthy Lifestyle Focused Care for People With Chronic Musculoskeletal Conditions Living in Rural Areas: a Non-interiority Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 5
- 主要终点
- Pain Impact
研究概览
简要总结
This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks.
Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation.
Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care.
Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.
详细描述
One in three Australians experience a musculoskeletal condition, with rural residents experiencing 10% to 30% greater burden. People with musculoskeletal conditions also experience higher rates of chronic health problems and higher prevalence of lifestyle risks (overweight, smoking, physically inactive and poor diet). As many as 75% of people with musculoskeletal conditions have three or more lifestyle risk factors, and those living in rural and remote areas have up to 10% increased prevalence of such risks compared to those living in metropolitan or regional areas. Poorer access to health services for musculoskeletal conditions means patients have higher attendance to emergency departments and increased hospitalisations, which also puts additional strain on tertiary healthcare systems. These factors contribute to a greater burden of musculoskeletal disease in rural populations that is 1.4 times higher than metropolitan populations.
Given the links between musculoskeletal conditions and lifestyle risks, and evidence from meta-analyses, many clinical practice guidelines recommend care for musculoskeletal conditions integrates a focus on lifestyle risks (e.g. weight or smoking). Moreover, surveys of patients with co-existing musculoskeletal conditions and lifestyle risks indicate that most have a preference for integrated care that addresses lifestyle risks. Despite this, less than 25% of such patients receive any support to improve lifestyle. The failure of health services to integrate care for pain and lifestyle risks is a missed opportunity to provide treatment that offers optimal therapeutic benefit for musculoskeletal conditions, supports prevention of chronic diseases, and provides patient-centred care.
A recent trial showed that integrating a healthy lifestyle focus into care for chronic back pain achieved larger improvements in disability, mental health and quality of life, compared to guideline recommended physiotherapy care only (without a lifestyle focus). Participants provided with at least 50% of the lifestyle intervention had large clinically meaningful benefit, suggesting better access to treatment may have large population benefit. Process evaluation of the trial revealed that patients wanted more flexible delivery options to access the intervention, including digital and virtual care options. In response to patient input, about better access to treatment, the HeLP-R trial was designed to compare following two delivery modalities of the program.
- An in-person physiotherapist-led model and referral to a telephone-based health coaching. This intervention aligns with how physiotherapist care is normally delivered in outpatient settings.
- A multidisciplinary model delivered remotely by virtual care, including physiotherapy, dietitian, psychology with additional smoking cessation or alcohol counselling, based on patient health needs. This intervention aligns with feedback from patients and clinicians to provide comprehensive yet flexible care.
MODEL OF CARE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All data will be analysed by an independent statistician blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and over, with one or more of the following chronic musculoskeletal conditions (pain or disability due to knee or hip, or non-specific low back pain) present for more than three months;
- •Average pain intensity over the last week of 3 or more on a 11-point numerical rating scale OR pain interference of at least 'somewhat' (3 out 5) on item 27 of the PROMIS 29;
- •At least one of the following lifestyle risk factors: Body Mass Index of greater than 25kg/m2, less than 30mins of physical activity on five or more days of the week, current smoker or vaper, consumes less than two serves of fruits or five serves of vegetables per day, drinks more than 10 standard drinks in a week, or more than 4 standard drinks on any one day, or 'poor' or 'very poor' sleep quality for item 6 of the Pittsburg Sleep Quality Index.
排除标准
- •Receiving healthcare for ALL eligible lifestyle risks;
- •Had bariatric surgery in the last 12 months or have planned bariatric surgery in the next 6 months;
- •Have planned orthopaedic surgery in the next 6 months;
- •Cannot actively or safely engage in the intervention or study procedures due to a medical comorbidity or constraint (e.g. impaired cognition, unable to use telehealth services, attend appointments, or adapt meals or activity);
- •Pain due to suspected serious cause, (e.g spinal infection, cancers, fracture, systemic rheumatic disease, cauda equina syndrome, diagnosis of radiculopathy);
- •Pregnant or planning pregnancy in the next 6 months.
研究组 & 干预措施
In-person physiotherapist-led pain and lifestyle care
Physiotherapist-led integrated healthy lifestyle and pain care delivered in-person with referral to telephone-based health coaching.
干预措施: In-person physiotherapist led integrated healthy lifestyle and pain care (Behavioral)
Virtual multidisciplinary pain and lifestyle care
Multidisciplinary integrated healthy lifestyle and pain care, involving a physiotherapist, dietitian, and psychologist, delivered remotely by virtual care.
干预措施: Virtual multidisciplinary integrated healthy lifestyle and pain care (Behavioral)
结局指标
主要结局
Pain Impact
时间窗: Baseline (enrolment), week 12, 26, 39 and 52.
Pain Impact is measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). PROMIS-29 is a validated self-report measure that assesses pain, function, and well-being in physical, mental, and social domains. The Pain Impact Score (range 8-50) uses pain intensity, physical function, and pain interference subdomains.
Pain Impact
时间窗: Baseline (enrolment), week 12, 26, 39 and 52.
Pain Impact is measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). PROMIS-29 is a validated self-report measure that assesses pain, function, and well-being in physical, mental, and social domains. The Pain Impact Score (range 8-50) uses pain intensity, physical function, and pain interference subdomains.
次要结局
- Physical Function(Baseline (enrolment), week 12, 26, 39 and 52.)
- Depression(Baseline (enrolment), week 12, 26, 39 and 52.)
- Anxiety(Baseline (enrolment), week 12, 26, 39 and 52.)
- Sleep disturbance(Baseline (enrolment), week 12, 26, 39 and 52.)
- Health-related quality of life(Baseline (enrolment), week 12, 26, 39 and 52.)
- Weight(Baseline (enrolment), week 12, 26, 39 and 52.)
- Pain self-efficacy(Baseline (enrolment), week 12, 26, 39 and 52.)
- Pain Intensity(Baseline (enrolment), week 12, 26, 39 and 52.)
- Physical activity levels(Baseline (enrolment), week 12, 26, 39 and 52.)
- Diet quality(Baseline (enrolment), week 12, 26, 39 and 52.)
- Smoking status(Baseline (enrolment), week 12, 26, 39 and 52.)
- Alcohol Consumption(Baseline (enrolment), week 12, 26, 39 and 52.)
- Pain beliefs(Baseline (enrolment), week 12, 26, 39 and 52.)
- Adverse events(Enrolment until end of treatment, and at week 12, 26, 39 and 52.)
- Pain Interference(Baseline (enrolment), week 12, 26, 39 and 52.)
- Fatigue(Baseline (enrolment), week 12, 26, 39 and 52.)
- Participation(Baseline (enrolment), week 12, 26, 39 and 52.)
- Cognition(Baseline (enrolment), week 12, 26, 39 and 52.)
- Weight(Baseline (enrolment), week 12, 26, and 52.)
- Pain self-efficacy(Baseline (enrolment), week 12, 26, and 52.)
- Physical activity levels(Baseline (enrolment), week 12, 26, and 52.)
- Diet quality(Baseline (enrolment), week 12, 26, and 52.)
- Smoking status(Baseline (enrolment), week 12, 26, and 52.)
- Alcohol Consumption(Baseline (enrolment), week 12, 26, and 52.)
- Pain beliefs(Baseline (enrolment), week 12, 26, and 52.)
- Pain Intensity(Baseline (enrolment), week 12, 26, 39 and 52.)
- Physical Function(Baseline (enrolment), week 12, 26, 39 and 52.)
- Depression(Baseline (enrolment), week 12, 26, 39 and 52.)
- Anxiety(Baseline (enrolment), week 12, 26, 39 and 52.)
- Sleep disturbance(Baseline (enrolment), week 12, 26, 39 and 52.)
- Health-related quality of life(Baseline (enrolment), week 12, 26, 39 and 52.)
- Weight(Baseline (enrolment), week 12, 26, 39 and 52.)
- Pain self-efficacy(Baseline (enrolment), week 12, 26, 39 and 52.)
- Physical activity levels(Baseline (enrolment), week 12, 26, 39 and 52.)
- Diet quality(Baseline (enrolment), week 12, 26, 39 and 52.)
- Smoking status(Baseline (enrolment), week 12, 26, 39 and 52.)
- Alcohol Consumption(Baseline (enrolment), week 12, 26, 39 and 52.)
- Pain beliefs(Baseline (enrolment), week 12, 26, 39 and 52.)
- Adverse events(Enrolment until end of treatment, and at week 12, 26, 39 and 52.)
- Pain Interference(Baseline (enrolment), week 12, 26, 39 and 52.)
- Fatigue(Baseline (enrolment), week 12, 26, 39 and 52.)
- Participation(Baseline (enrolment), week 12, 26, 39 and 52.)
- Cognition(Baseline (enrolment), week 12, 26, 39 and 52.)