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

NCT05056623 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Chronic Pain
  • Elderly
  • Informal Caregivers
  • Dyadic Intervention

Interventions

BEHAVIORAL

Dyadic pain management program

Face-to-face part: The DPM will start with 20-30 minutes of physical exercise supervised by research assistant, followed by 20-minutes of pain management education. Communication skills regarding the practice of various pain management techniques by the participants and their caregivers will be taught. At the end of the session, the caregiver and research assistant will help the older adults to make portfolio entries on the activities of the day, to help them recall the various pain-relief methods learned in each class. Home-based part: An exercise book will be given to guide them in performing exercises at home. It is recommended to perform 30 minutes of exercise, 3 times a week, at home and the more frequent the exercise time, the better. All participants will join a WhatsApp group to receive teaching materials and videos of the physical exercises learned, for practice at home. The team will produce compact disc (CD) with the exercise video clips to the dyads for revision.

OTHER

Usual care and pain management pamphlet

Usual care and pain management pamphlet

Sponsors & Collaborators

  • Health and Medical Research Fund

    collaborator OTHER_GOV
  • Shatin Hospital

    collaborator OTHER
  • The Hong Kong Polytechnic University

    collaborator OTHER
  • The University of Hong Kong

    collaborator OTHER
  • Hong Kong Metropolitan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2024-09-01
Completion
2024-12-01

Countries

  • Hong Kong

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056623 on ClinicalTrials.gov