Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain
Active, not recruitingNot applicableNCT05056623
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain: a Cluster Randomized Controlled Trial
- Conditions
- Chronic Pain
- Elderly
- Informal Caregivers
- Dyadic Intervention
- Interventions
- Behavioral: Dyadic pain management program
- Other: Usual care and pain management pamphlet
- Sponsor
- Hong Kong Metropolitan University
- Collaborators
- Health and Medical Research Fund; Shatin Hospital; The Hong Kong Polytechnic University; The University of Hong Kong
- Start date
- 2022-07-14
- Primary completion
- 2024-09-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Hong Kong
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Older adults / Participants: Inclusion criteria * Aged 60 or above who are mainly cared for by an informal caregiver and willing to participate the DPM together * scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid in differentiating between normal and abnormal cognitive functions for geriatric clients29 Can understand Cantonese * Have a history of non-cancer pain in the past 6 months * Have a pain score of at least 2 on the Numeric Rating Scale (0-11 numeric scale) * Able to take part in light exercise and stretching * One member of the dyad owns a smart phone and can access the Internet Older adults / Participants: Exclusion criteria * Have a serious organic disease or malignant tumor * Have a mental disorder diagnosed by neurologists or psychiatrists * Will have further medical/surgical treatment in two months * Experienced drug addiction18 Informal Caregivers : Inclusion criteria * Aged 18 or above * As an informal caregiver for the participating older adult * scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid in differentiating between normal and abnormal cognitive functions for geriatric clients * Can understand Chinese * Have a history of non-cancer pain in the past 6 months * Have a pain score of at least 2 on the Numeric Rating Scale (0-11 numeric scale) * Able to take part in light exercise and stretching * Own a smart phone and can assess the internet * Able to attend the whole sessions in community activity center Informal Caregivers: Exclusion criteria * Have serious organic disease or malignant tumor * Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists * Have a further medical/surgical treatment in two months or have joined in other pain management program * Experience a drug addiction problem
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05056623