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

Primary Purpose

Chronic Pain, Elderly, Informal Caregivers

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dyadic pain management program
Usual care and pain management pamphlet
Sponsored by
Hong Kong Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hong Kong Metropolitan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dyadic pain management program

Usual care and pain management pamphlet

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain self-efficacy
A Chinese version of the Pain Self-Efficacy Questionnaire (PSEQ) will be used to measure self-efficacy in coping with activities despite pain. Minimum score = 0; Maximum score = 60. Higher scores mean a better outcome.
Perceived quality of life
The Chinese version of the EuroQoL 5-dimension 5-level version (EQ-5D-5L) will be used to measure quality of life of participants as well as the cost effectiveness of the proposed dyadic pain management program. It is a health-related quality of life measure developed by the EuroQol Group. Minimum score = 0; Maximum score = 100. Higher scores means a better outcome.
Psychological health : Depression, anxiety, & stress
The Depression Anxiety Stress Scales 21-items (DASS-21) is a self-administered psychological instrument to evaluate degrees of depression, anxiety, and stress. Minimum score. Minimum score = 0; Maximum score: Depression = 28+, Anxiety = 20+, Stress = 37+. Higher score means a worse outcome.
Physical function: 6-minute walk test
A 6-minute walk test to test exercise tolerance in chronic disease.
Caregiver Burden Inventory (for the caregivers only)
The Caregiver Burden Inventory comprises 24 items measuring five dimensions of burden related to the caregiving role. Minimum score = 0; Maximum score 96. Higher score means a worse outcome.
Process evaluation
A process evaluation will be carried out to identify the strengths and limitations of the intervention from the perspectives of the older adults and their caregivers
Field observations
To monitor the quality of the implementation of the DPM. A total of 48 observations will be conducted by the principal investigator, guided by a fidelity checklist. 9 The checklist indicates the implementation of DPM in terms of four levels: low/not observed; observed to a small degree; observed to a medium degree, and high implementation.
Knowledge and skills acquired in managing pain situations for older adults
A questionnaire will be given to the participants in the experimental and control groups regarding their knowledge and skills in managing pain situations. Minimum score = 0, Maximum score = 10. Higher score means a better outcome.
Semi-structured interviews for older adults and their caregivers
To obtain the widest range of opinions and comments from different perspectives, equal proportions of participants 1) with significant positive changes between the baseline and first post-test measurements, 2) without significant changes, and 3) with negative changes, will be invited for interviews. They will be asked to comment on their experiences and feelings about the intervention that they received and on changes in their behavior, their perceptions of the intervention, their beliefs, concerns, and views of the difficulties of managing pain; and how the intervention could be improved to meet their needs.

Full Information

First Posted
March 24, 2021
Last Updated
September 21, 2023
Sponsor
Hong Kong Metropolitan University
Collaborators
Health and Medical Research Fund, The University of Hong Kong, Shatin Hospital, The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05056623
Brief Title
Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults With Chronic Pain
Official Title
Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults With Chronic Pain: a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Metropolitan University
Collaborators
Health and Medical Research Fund, The University of Hong Kong, Shatin Hospital, The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Elderly, Informal Caregivers, Dyadic Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dyadic pain management program
Arm Type
Experimental
Arm 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.
Arm Title
Usual care and pain management pamphlet
Arm Type
Other
Arm Description
The participants in the control group will receive the usual care and a pain management pamphlet.
Intervention Type
Behavioral
Intervention Name(s)
Dyadic pain management program
Intervention Description
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
Other
Intervention Name(s)
Usual care and pain management pamphlet
Intervention Description
Usual care and pain management pamphlet
Primary Outcome Measure Information:
Title
Change from baseline pain intensity at week 16
Description
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.
Time Frame
Baseline to week 16
Secondary Outcome Measure Information:
Title
Pain self-efficacy
Description
A Chinese version of the Pain Self-Efficacy Questionnaire (PSEQ) will be used to measure self-efficacy in coping with activities despite pain. Minimum score = 0; Maximum score = 60. Higher scores mean a better outcome.
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Perceived quality of life
Description
The Chinese version of the EuroQoL 5-dimension 5-level version (EQ-5D-5L) will be used to measure quality of life of participants as well as the cost effectiveness of the proposed dyadic pain management program. It is a health-related quality of life measure developed by the EuroQol Group. Minimum score = 0; Maximum score = 100. Higher scores means a better outcome.
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Psychological health : Depression, anxiety, & stress
Description
The Depression Anxiety Stress Scales 21-items (DASS-21) is a self-administered psychological instrument to evaluate degrees of depression, anxiety, and stress. Minimum score. Minimum score = 0; Maximum score: Depression = 28+, Anxiety = 20+, Stress = 37+. Higher score means a worse outcome.
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Physical function: 6-minute walk test
Description
A 6-minute walk test to test exercise tolerance in chronic disease.
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Caregiver Burden Inventory (for the caregivers only)
Description
The Caregiver Burden Inventory comprises 24 items measuring five dimensions of burden related to the caregiving role. Minimum score = 0; Maximum score 96. Higher score means a worse outcome.
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Process evaluation
Description
A process evaluation will be carried out to identify the strengths and limitations of the intervention from the perspectives of the older adults and their caregivers
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Field observations
Description
To monitor the quality of the implementation of the DPM. A total of 48 observations will be conducted by the principal investigator, guided by a fidelity checklist. 9 The checklist indicates the implementation of DPM in terms of four levels: low/not observed; observed to a small degree; observed to a medium degree, and high implementation.
Time Frame
Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program
Title
Knowledge and skills acquired in managing pain situations for older adults
Description
A questionnaire will be given to the participants in the experimental and control groups regarding their knowledge and skills in managing pain situations. Minimum score = 0, Maximum score = 10. Higher score means a better outcome.
Time Frame
Baseline (T0), week 8 (T1), week 16 (T2)
Title
Semi-structured interviews for older adults and their caregivers
Description
To obtain the widest range of opinions and comments from different perspectives, equal proportions of participants 1) with significant positive changes between the baseline and first post-test measurements, 2) without significant changes, and 3) with negative changes, will be invited for interviews. They will be asked to comment on their experiences and feelings about the intervention that they received and on changes in their behavior, their perceptions of the intervention, their beliefs, concerns, and views of the difficulties of managing pain; and how the intervention could be improved to meet their needs.
Time Frame
Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mimi MY Tse, PhD
Phone
852 3970 8764
Email
mmytse@hkmu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Mimi MY Tse
Phone
852 3970 8764
Email
mmytse@hkmu.edu.hk
Facility Information:
Facility Name
Hong Kong Metropolitan University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mimi MY Tse

12. IPD Sharing Statement

Plan to Share IPD
No

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

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