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

NCT04106271 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-07-29

No results posted yet for this study

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

Interventions

OTHER

dyadic pain management program

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.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Tse Tse, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2022-06-28
Completion
2022-06-28

Countries

  • Hong Kong

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106271 on ClinicalTrials.gov