Clinical Trial

Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Objective: To evaluate the effectiveness of a dyadic pain management program (DPM) in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function in older adults. Hypothesis: DPM is more effective in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function among older adults than the usual care, upon completion of the DPM (week 8) and over time (week 16). Design and subjects: Clustered randomized controlled trial with neighborhood elderly centers (NEC) as cluster; 150 dyads (one older adults and his/her caregiver as one dyad) will be recruited from 22 NEC clusters. Each NEC will be randomly allocated to experimental group (receive DPM), control group (receive usual care and pain management pamphlet). Study instruments: Brief Pain Inventory; Pain Self-Efficacy Questionnaire; Short Form Health Survey-12; Depression, anxiety \& stress; Caregiver Burden Inventory; 6-minute walk test and process evaluation. Intervention: DPM, each session includes exercise, interactive pain management education, practices on non-drug techniques and using a WhatsApp (WhatsApp Messenger) group to encourage home-based exercise and practice of non-drug methods. Outcome measures: Pain intensity, pain self-efficacy, perceived health-related quality of life and experience in participating DPM, to be collected at baseline (T0), week 8 (T1), and week 16 (T2). Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for within-group and between- group comparisons.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-09-23; most recent amendment 2024-10-04.
Status change: Recruiting → Active, Not Recruiting 2024-10-01
Status change: Not Yet Recruiting → Recruiting 2022-08-03
Trial Details
NCT Number NCT05056623
Lead Sponsor Hong Kong Metropolitan University
Collaborators: Health and Medical Research Fund, Shatin Hospital, The Hong Kong Polytechnic University, The University of Hong Kong
Conditions Chronic Pain, Elderly, Informal Caregivers, Dyadic Intervention
Enrollment 150 participants
Start Date 2022-07-14
Primary Completion 2024-09-01 (estimated)
Study Completion 2024-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-08