The Effectiveness of a Dyadic Pain Management Program for Older People and Informal Caregivers With Chronic Pain: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain intensity and pain interference
研究概览
简要总结
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.
详细描述
Participants
This study is a dyadic intervention. Target populations are older adults and informal caregivers with chronic pain. A pair of informal caregiver and older adult will be regarded as a dyad. Dyads will be recruited in the community following the snowball sampling, the eligibility will be accessed based on the following details:
Older adults
Inclusion criteria 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •Able to attend the whole sessions in community activity center.
排除标准
- •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.
结局指标
主要结局
Pain intensity and pain interference
时间窗: Baseline, Week 4, one-month after intervention
Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory
次要结局
- 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)
研究者
TSE Mun Yee Mimi
Associate professor
The Hong Kong Polytechnic University