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

Chronic Pain Clinical Trial

Official title:

Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults With Chronic Pain: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056623
• Other study ID #: DPM
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: Hong Kong Metropolitan University
• Contact: Mimi MY Tse, PhD
• Phone: 852 3970 8764
• Email: mmytse[@]hkmu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Elderly
• Informal Caregivers

Intervention

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.

Other:
• Usual care and pain management pamphlet
Usual care and pain management pamphlet

Locations

Country	Name	City	State
Hong Kong	Hong Kong Metropolitan University	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University	Health and Medical Research Fund, Shatin Hospital, The Hong Kong Polytechnic University, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	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.	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	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.	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	Physical function: 6-minute walk test	A 6-minute walk test to test exercise tolerance in chronic disease.	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	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.	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	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	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	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.	Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program
Secondary	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.	Baseline (T0), week 8 (T1), week 16 (T2)
Secondary	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.	Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1