Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain: a Cluster Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Hong Kong Metropolitan University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline pain intensity at week 16
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
The DPM is an 8-week group-based program. The DPM included 4 weeks of center-based, face-to-face activities and 4 weeks digital-based activities delivered via a WhatsApp group. An 80% participation rate in the face-to-face activities will be regarded as completion of the DPM. Timely make-up sessions will be arranged for those unable to attend the scheduled session.
Investigators
Professor Mimi TSE Mun Yee
Professor
Hong Kong Metropolitan University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline pain intensity at week 16
Time Frame: Baseline to week 16
The Chinese version of the Brief Pain Inventory will be used to assess the multidimensional nature of pain, including intensity and interference with life activities in the previous 24 hours. Minimum score = 0; Maximum score = 10. Higher scores mean a worse outcome.
Secondary Outcomes
- Physical function: 6-minute walk test(Baseline (T0), week 8 (T1), week 16 (T2))
- Semi-structured interviews for older adults and their caregivers(Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1)
- Perceived quality of life(Baseline (T0), week 8 (T1), week 16 (T2))
- Caregiver Burden Inventory (for the caregivers only)(Baseline (T0), week 8 (T1), week 16 (T2))
- Process evaluation(Baseline (T0), week 8 (T1), week 16 (T2))
- Pain self-efficacy(Baseline (T0), week 8 (T1), week 16 (T2))
- Psychological health : Depression, anxiety, & stress(Baseline (T0), week 8 (T1), week 16 (T2))
- Field observations(Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program)
- Knowledge and skills acquired in managing pain situations for older adults(Baseline (T0), week 8 (T1), week 16 (T2))