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

NCT05056623 | Active Not Recruiting

• 1 other identifier: DPM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Elderly; Informal Caregivers; Dyadic Intervention

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain intensity at 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.

  Baseline to week 16

Secondary Outcomes (9)

• Pain self-efficacy

  Baseline (T0), week 8 (T1), week 16 (T2)

• Perceived quality of life

  Baseline (T0), week 8 (T1), week 16 (T2)

• Psychological health : Depression, anxiety, & stress

  Baseline (T0), week 8 (T1), week 16 (T2)

• Physical function: 6-minute walk test

  Baseline (T0), week 8 (T1), week 16 (T2)

• Caregiver Burden Inventory (for the caregivers only)

  Baseline (T0), week 8 (T1), week 16 (T2)

Study Arms (2)

Dyadic pain management program

EXPERIMENTAL

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.

Behavioral: Dyadic pain management program

Usual care and pain management pamphlet

OTHER

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

Other: Usual care and pain management pamphlet

Interventions

Dyadic pain management program 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.

Dyadic pain management program

Usual care and pain management pamphlet OTHER

Usual care and pain management pamphlet

Usual care and pain management pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Have serious organic disease or malignant tumor
• Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• Health and Medical Research Fund: collaborator
• Shatin Hospital: collaborator
• The Hong Kong Polytechnic University: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: September 24, 2021
• Study Start: July 14, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)