Dyadic Pain Management Program for Older Adults and Informal Caregivers With Chronic Pain

NCT04106271 | Unknown

• 1 other identifier: DPMCP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is a common health problem among older adults and their informal caregivers. Chronic pain has negative effects on physical and psychological health status and it is a strong predictor of poor quality of life. In this study, a dyadic face-to-face pain management program will be provided to older adults and informal caregivers to help the dyads equip with pain-related knowledge and pain coping skills. The effectiveness of the dyadic program will be assessed. Participants will be recruited follow snowball sampling and will be randomly allocated to experimental group and control group using 1: 1 radio. The dyadic pain management program will last four weeks, including group discussion, pain-related knowledge and physical exercises. Pain intensity, anxiety, depression, stress, pain self-efficacy and quality of life will be measured in baseline, post-treatment and at one-month follow. Acceptability and satisfaction to the program will be collected. This study will be held in Caritas District Elderly Centre-Yeun Long (Tin Chak Centre) and Caritas Cheng Shing Fung District Elderly Center (Shamshuipo) in Hong Kong. For sample size, no suitable standard deviation and effect size was found in previous similar study through the literature review, so this study will be a pilot RCT study with a total 60 dyads of sample size. 30 older adults and 30 informal caregivers will be in each group (experimental group and control group). The dyadic pain management program will be held in the community activity center at weekends and will involve three parts: demographic data, outcome measures (baseline, post-treatment and one-month follow-up measures) and pain education. Potential participants' eligibility will be confirmed by a questionnaire designed according to inclusion criteria and exclusion criteria. An information sheet will be provided to the eligible dyads and informed consent will be signed on the scene. Experimental group will start pain management program when finish the baseline assessment and control group will be given one page of pain management information download from Department of Health. (http://www.elderly.gov.hk/english/common\_health\_problems/bones\_and\_joints/index.html). For optimal communication, two WhatsApp groups will be created consisting of all the caregivers in experimental group and control group respectively. Outcomes will be measured at three times during the whole intervention, T0 baseline prior to intervention, T1 in week four when the experimental group finish all the program and T2 in week eight with one-month follow-up after the program. Dyads' demographic and caregiving-related questions will be completed prior to beginning the program in T0. Pain related situations, anxiety, depression, stress, quality of life, pain self-efficacy will be measured from older adults and informal caregivers at T0, T1, T2, using a same battery of questionnaires. Dyads' acceptability and satisfaction will be administered immediately after the last session. Data will be collected by a research assistant blinded to the dyads' group assignments.

Conditions

Chronic Pain

Keywords

Chronic Pain; dyadic pain management program; older adults; informal caregiver

Outcome Measures

Primary Outcomes (1)

• Pain intensity and pain interference

  Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory

  Baseline, Week 4, one-month after intervention

Secondary Outcomes (4)

• Depression, Anxiety and Stress

  Baseline, Week 4, one-month after intervention

• Pain self-efficacy

  Baseline, Week 4, one-month after intervention

• World Health Organization Quality of Life-Brief

  Baseline, Week 4, one-month after intervention

• Participant's Satisfaction and acceptability to the program

  week 4

Study Arms (2)

Experimental group

EXPERIMENTAL

dyadic pain management program will be accessible by the intervention group

Other: dyadic pain management program

Control group

NO INTERVENTION

No intervention for the control group, only one-page simple material related to pain will be provided.

Interventions

dyadic pain management program OTHER

a dyadic pain management program for older adults and their informal caregivers is developed as intervention. The program will be conducted at community activity center face-to-face combined with digital-based activities and the program will include 4 sessions, weekly 1 hours. Each session will be classified into three stages, including 10 minutes for watching videos and group discussion, 20 minutes for theoretical knowledge and coping skills and 20 minutes for exercising together. Last 10 minutes of each session is to wrap up and Q \& A. There will be a brief introduction of program and self-introduction of participants at the beginning of the first session. One exercise book is given to each pair and researchers have a 4-week follow-up.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Older adults:
• Aged 65 or above;
• Have an informal caregiver willing to participate this program;
• Can understand Chinese;
• Have a history of non-cancer pain in past 6 months;
• Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale;
• Have behavioral abilities to do a light exercise and stretch program;
• Able to attend the whole sessions in community activity center.
• For Informal caregivers:
• Aged 18 or above;
• As an informal caregiver for one older adult;
• Can understand Chinese;
• Have a history of non-cancer pain in past 6 months;
• Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale;
• Own a smartphone and can assess the internet;

You may not qualify if:

• For Older adults:
• 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.
• For Informal caregivers:
• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing

Hung Hom, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Tse Tse, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mimi Tse, PhD

CONTACT

852-27666541; mimi.tse@polyu.edu.hk

Study Design

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

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: June 28, 2019
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)