Promotion of Physical Activity Through Telehealth-delivered Support of Engagement in Daily Occupations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
Background: Previous research has demonstrated that people living with chronic pain who were physically active could better protect themselves from chronicity. Chronic pain population has high motivation for initiating lifestyle changes as a part of their multidisciplinary chronic pain treatment but are often not offered any intervention to improve lifestyle.
Objectives: The project will evaluate feasibility of a telehealth-delivered intervention to promote compliance with current WHO recommendations on weekly moderate-to-vigorous physical activity (MVPA) through increased engagement in daily occupations in adults living with chronic. The feasibility evaluation will inform the design and conduct of a future randomised controlled trial (RCT).
Method: Forty adults over 18 years old, living a sedentary lifestyle (i.e., self-reported MVPA<150 min./ week) and completed their standard specialized multidisciplinary chronic pain rehabilitation at Naestved hospital will be invited to participate in this one-group pretest-post-test study. A mixed methods methodology will be applied to investigate in feasibility outcomes (primary) with green-amber-red method, moderate-to-vigorous physical activity, occupational performance and satisfaction and occupational balance in meaningful daily activities, pain spreading, pain intensity, central sensitization, pain self-efficacy, pain catastrophizing, health-related quality of life (HRQoL) and satisfaction with the treatment.
With inspiration from a previous research project with a three-fold focus on meaningful activities, physical activity and eating habits that demonstrated the potential of occupational therapy in lifestyle management in the everyday context, the 12-week occupational therapy individual person-centered intervention will include 1-hour video appointments a week in four weeks and a maintenance phase of similar session format every second week in two months. Individual interviews will add in-depth knowledge on the patients' opinions on the intervention's mechanism and design.
详细描述
Methods Design A mixed methods feasibility study will be applied to investigate whether MVPA level in adults living with chronic pain can be optimized with an occupational therapy telehealth intervention. One-group pretest-post-test study will assess feasibility outcomes with green-amber-red method, MVPA, occupational performance and satisfaction and occupational balance in meaningful daily activities, pain spreading, pain intensity, central sensitization, pain self-efficacy, pain catastrophizing, health-related quality of life (HRQoL) and satisfaction with the treatment. Individual interviews will add in-depth knowledge on the patients' opinions on the intervention's mechanism and design. The participants' activity diary notes will support the quantitative and qualitative data collected.
Participants The project participants will represent adults living with chronic pain and referred to tertiary chronic pain rehabilitation at a hospital.
Inclusion criteria: Adults over 18 years old, living a sedentary lifestyle (i.e., self-reported MVPA <150 min./ week) and diagnosed with fibromyalgia or musculoskeletal pain in low back, knees, legs, neck, arms and shoulders, who completed their chronic pain treatment at the Multidisciplinary Pain Centre (MPC) at Naestved hospital will be invited to participate.
Exclusion criteria: Adults referred to other specialized treatments or health services (e.g., delivered by rheumatologists, psychiatrists, physiotherapists or multidisciplinary) after the tertiary chronic pain rehabilitation, not sufficient Danish writing and speaking proficiency to allow independent questionnaire completion and translation-free conversation.
Settings Occupational Therapy Unit (OTU) at Naestved hospital in collaboration with the Multidisciplinary Pain Centre (MPC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults over 18 years old
- •Completed their chronic pain treatment at the Multidisciplinary Pain Centre (MPC) at Naestved hospital
- •Self-reported MVPA <150 min./ week)
- •Diagnoses such as fibromyalgia or musculoskeletal pain in low back, knees, legs, neck, arms and shoulders
排除标准
- •Referral to other specialized treatments or health services (e.g., delivered by rheumatologists, psychiatrists, physiotherapists or multidisciplinary)
- •Not sufficient Danish writing and speaking proficiency allowing independent questionnaire completion and translation-free conversation
结局指标
主要结局
Adverse events
时间窗: After 3 months
n, % caused discontinuation, post-intervention
Program adherence
时间窗: After 3 months
% mean of participation in the sessions planned, post-intervention
Participant retention
时间窗: After 3 months
% mean of completed the assessments planned, post-intervention
Recruitment rate
时间窗: Through study completion, on average 6 months
Mean n recruited per month
Patients' self-perceived relevance, timing and mode of delivery
时间窗: After 3 months
% mean of positive patients' feedback regarding the intervention's relevance, timing and mode of delivery, post-intervention
Fidelity of delivery
时间窗: After 3 months
% of contents delivered as planned, post-intervention
Assessment procedure acceptance
时间窗: After 3 months
% mean of positive response, post-intervention
次要结局
- Change in Occupational performance and satisfaction after 3 months(After 3 months)
- Change in Pain intensity after 3 months(After 3 months)
- Change in Central sensitization after 3 months(After 3 months)
- Change in Pain catastrophizing after 3 months(After 3 months)
- Change in Sleep quality after 3 months(After 3 months)
- Change in Occupational balance after 3 months(After 3 months)
- Change in Pain spreading after 3 months(After 3 months)
- Change in Health-related quality of life (HRQoL) after 3 months(After 3 months)
- Change in Treatment satisfaction after 3 months(After 3 months)
- Change in MVPA time after 3 months(After 3 months)
- Change in Pain self-efficacy after 3 months(After 3 months)
研究者
Svetlana Solgaard Nielsen
Principal Investigator
Slagelse Hospital