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

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ClinicalTrials.gov Identifier: NCT05056623
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborators:
Health and Medical Research Fund
The University of Hong Kong
Shatin Hospital
Information provided by (Responsible Party):
TSE Mun Yee Mimi, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Elderly Informal Caregivers Dyadic Intervention Behavioral: Dyadic pain management program Other: Usual care and pain management pamphlet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults With Chronic Pain: a Cluster Randomized Controlled Trial
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain self-efficacy [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    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.

  2. Perceived quality of life [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    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.

  3. Psychological health : Depression, anxiety, & stress [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    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.

  4. Physical function: 6-minute walk test [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    A 6-minute walk test to test exercise tolerance in chronic disease.

  5. Caregiver Burden Inventory (for the caregivers only) [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    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.

  6. Process evaluation [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    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

  7. Field observations [ Time Frame: Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program ]
    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.

  8. Knowledge and skills acquired in managing pain situations for older adults [ Time Frame: Baseline (T0), week 8 (T1), week 16 (T2) ]
    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.

  9. Semi-structured interviews for older adults and their caregivers [ Time Frame: Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056623


Contacts
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Contact: Mimi MY Tse, PhD 852 2766 6541 mimi.tse@polyu.edu.hk
Contact: Mimi MY Tse 852 2766 6541 mimi.tse@polyu.edu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
Health and Medical Research Fund
The University of Hong Kong
Shatin Hospital
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Responsible Party: TSE Mun Yee Mimi, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT05056623    
Other Study ID Numbers: DPM
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations