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

NCT ID: NCT05056623

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2024-12-01

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.

Conditions

Chronic Pain; Elderly; Informal Caregivers; Dyadic Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Dyadic pain management program

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.

Group Type: EXPERIMENTAL

Dyadic pain management program

Intervention Type: BEHAVIORAL

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.

Usual care and pain management pamphlet

The participants in the control group will receive the usual care and a pain management pamphlet.

Group Type: OTHER

Usual care and pain management pamphlet

Intervention Type: OTHER

Usual care and pain management pamphlet

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care and pain management pamphlet

Usual care and pain management pamphlet

Intervention Type: OTHER

Eligibility Criteria

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

• 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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health and Medical Research Fund

OTHER_GOV

Sponsor Role: collaborator

Shatin Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Hong Kong Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Professor Mimi TSE Mun Yee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hong Kong Metropolitan University

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

DPM

Identifier Type: -

Identifier Source: org_study_id