Chronic Pain Clinical Trial
Official title:
The Effectiveness of a Dyadic Pain Management Program for Older People and Informal Caregivers With Chronic Pain: A Pilot Randomized Controlled Trial
NCT number | NCT04106271 |
Other study ID # | DPMCP |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2019 |
Est. completion date | June 28, 2022 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 28, 2022 |
Est. primary completion date | June 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: For Older adults: 1. Aged 65 or above; 2. Have an informal caregiver willing to participate this program; 3. Can understand Chinese; 4. Have a history of non-cancer pain in past 6 months; 5. Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale; 6. Have behavioral abilities to do a light exercise and stretch program; 7. Able to attend the whole sessions in community activity center. For Informal caregivers: 1. Aged 18 or above; 2. As an informal caregiver for one older adult; 3. Can understand Chinese; 4. Have a history of non-cancer pain in past 6 months; 5. Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale; 6. Own a smartphone and can assess the internet; 7. Able to attend the whole sessions in community activity center. Exclusion Criteria: For Older adults: 1. Have serious organic disease or malignant tumor; 2. Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists; 3. Have a further medical/surgical treatment in two months or have joined in other pain management program. 4. Experience a drug addiction problem. For Informal caregivers: 1. Have serious organic disease or malignant tumor; 2. Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists; 3. Have a further medical/surgical treatment in two months or have joined in other pain management program. 4. Experience a drug addiction problem. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | School of Nursing | Hung Hom | Kowloon |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Depression, Anxiety and Stress | Changes from baseline to Week 4 and one-month after the intervention in depression, anxiety and stress using Depression Anxiety Stress Scale - 21 Scale (DASS-21#. The DASS-21 is a set of three self-reported scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items and divided into subscales. The score of each item ranges feom 0 to 3 (o = do not apply to me at all, 3 = applied to me very much or most of the time). Total score is multiplied by 2 of the sum of each subscales. Higher score indicates the greater degree of the symptom. | Baseline, Week 4, one-month after intervention | |
Secondary | Pain self-efficacy | Changes from baseline to Week 4 and one-month after the intervention in pain self-efficacy using Pain Self-Efficacy Questionnaire (PSEQ). PSEQ is a 10-item questionnaire assessing the confidence people with ongoing pain have in performing activities while in pain. Score of each item ranges from 0 to 6 (0 = not at all confident, 6 = completely confident). A total score is calculated by adding the scores for each item which ranging from 0 to 60. Higher scores reflect stronger self-efficacy beliefs. | Baseline, Week 4, one-month after intervention | |
Secondary | World Health Organization Quality of Life-Brief | Changes from baseline to Week 4 and one-month after the intervention in quality of life using World Health Organization Quality of Life-Brief. It is a self-report questionnaire which assesses 4 domains of quality of life, including physical health, psychological health, social relationships, and environment. Participants will express how much they have experienced in the preceding two weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). | Baseline, Week 4, one-month after intervention | |
Secondary | Participant's Satisfaction and acceptability to the program | Participants satisfaction and acceptability to the online pain education program will be assessed at post-treatment by several questions, including "do you think this online pain education program useful?" "does it worth your time following the program?" "would you feel confident to recommend this program to others?" Participants are required to answer the questions by "Yes" or "No". Open-ended question "what are the advantages and disadvantages of the program?" will also be asked. These questions have in the previous studies to assess the acceptability and satisfaction to the internet-delivered program. | week 4 |
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