Physically Active Through Daily Occupations With Telehealth

NCT05322928 | Completed

• 1 other identifier: SSN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

activities of daily living; habits; health behavior; occupational therapy; sedentary lifestyle

Outcome Measures

Primary Outcomes (7)

• Recruitment rate

  Mean n recruited per month

  Through study completion, on average 6 months

• Participant retention

  % mean of completed the assessments planned, post-intervention

  After 3 months

• Program adherence

  % mean of participation in the sessions planned, post-intervention

  After 3 months

• Patients' self-perceived relevance, timing and mode of delivery

  % mean of positive patients' feedback regarding the intervention's relevance, timing and mode of delivery, post-intervention

  After 3 months

• Assessment procedure acceptance

  % mean of positive response, post-intervention

  After 3 months

• Adverse events

  n, % caused discontinuation, post-intervention

  After 3 months

• Fidelity of delivery

  % of contents delivered as planned, post-intervention

  After 3 months

Secondary Outcomes (11)

• Change in MVPA time after 3 months

  After 3 months

• Change in Occupational performance and satisfaction after 3 months

  After 3 months

• Change in Occupational balance after 3 months

  After 3 months

• Change in Pain intensity after 3 months

  After 3 months

• Change in Pain self-efficacy after 3 months

  After 3 months

Other Outcomes (3)

• Accessibility after 3 months

  After 3 months

• Practicability after 3 months

  After 3 months

• Accept after 3 months

  After 3 months

Study Arms (1)

Engagement in daily occupations

EXPERIMENTAL

The experimental contents will include 1-hour video appointments with an occupational therapist a week in four weeks and a maintenance phase of similar session format every second week in two months.

Behavioral: Engagement in daily occupations

Interventions

Engagement in daily occupations BEHAVIORAL

The 12-week occupational therapy individual person-centered intervention will be delivered by an occupational therapist according to the individual intervention plan, with a 1-hour video appointment (Region Zealand VDX-connection) a week in four weeks and a maintenance phase of similar session format every second week in two months. The intervention will include identification of occupational problems that limit compliance with the PA recommendations, setting tailored occupational goals to enhance physically active lifestyle, supervised goal work and goal evaluation. Through active involvement in value-based prioritizing, planning and performance of meaningful everyday activities, the participants will reduce their sedentary time. Changing health behaviour in a stepwise manner, the participants will become prepared for continuous lifestyle goal work as self-management which will allow for sustainable lifestyle changes, and thus, improved long-term health and quality of life.

Engagement in daily occupations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Slagelse Hospital: lead
• Naestved Hospital: collaborator

Study Sites (1)

Naestved, Slagelse and Ringsted Hospitals

Slagelse, Region Sjælland, 4200, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Habits; Health Behavior; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Søren T. Skou, PhD

  Department of Physiotherapy and Occupational Therapy

  STUDY DIRECTOR

• Lars Tang, PhD

  Department of Physiotherapy and Occupational Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 12, 2022
• Study Start: March 1, 2022
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

DK (1)