Promotion of Physical Activity Through Telehealth-delivered Support of Engagement in Daily Occupations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
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.
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Adverse events
Time Frame: After 3 months
n, % caused discontinuation, post-intervention
Program adherence
Time Frame: After 3 months
% mean of participation in the sessions planned, post-intervention
Participant retention
Time Frame: After 3 months
% mean of completed the assessments planned, post-intervention
Recruitment rate
Time Frame: Through study completion, on average 6 months
Mean n recruited per month
Patients' self-perceived relevance, timing and mode of delivery
Time Frame: After 3 months
% mean of positive patients' feedback regarding the intervention's relevance, timing and mode of delivery, post-intervention
Fidelity of delivery
Time Frame: After 3 months
% of contents delivered as planned, post-intervention
Assessment procedure acceptance
Time Frame: After 3 months
% mean of positive response, post-intervention
Secondary Outcomes
- 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)
Investigators
Svetlana Solgaard Nielsen
Principal Investigator
Slagelse Hospital