Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04106271
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2019-09-25
Brief Title:
Dyadic Pain Management Program for Older Adults and Informal Caregivers With Chronic Pain
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
The Effectiveness of a Dyadic Pain Management Program for Older People and Informal Caregivers With Chronic Pain A Pilot Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 httpwwwelderlygovhkenglishcommon_health_problemsbones_and_jointsindexhtml 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
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 httpwwwelderlygovhkenglishcommon_health_problemsbones_and_jointsindexhtml 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
Detailed Description:
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
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
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 medicalsurgical treatment in two months or have joined in other pain management program
4 Experience a drug addiction problem
Informal caregivers Inclusion criteria 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 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 medicalsurgical treatment in two months or have joined in other pain management program
4 Experience a drug addiction problem
Outcome measures It is a dyadic intervention so outcomes will be measured from older adults and informal caregivers
Primary outcome The Brief Pain Inventory-Chinese Version It is a tool to evaluate the intensity site quality relief interference and causes of pain in patients Four items for the degree of pain severity one item for the degree of pain relief and seven items for degree of pain interferes will assess numbering the different pain sites from 0 to 10 For BPI-C the Cronbachs α for the pain severity and pain interference items are 083-089 and 090-091 and has good acceptable test-retest reliability
Secondary outcomes
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 Previous studies showed that WHOQOL-BRIF has good internal consistency and validity
Depression Anxiety Stress Scale It is a self-administered psychological instrument to evaluate the degree of depression anxiety and stress involving 21 items Every part has seven items on a 4-point Likert scale ranging from 0 to 3 The instrument was used in previous studies and had good internal consistency and validity
Pain Self-efficacy Questionnaire It is a tool to measure the self-efficacy in coping with daily activities with pain A Chinese version of the PSEQ will be used in this study Participants will express participants confidence in performing ten activities experiencing pain on a 7-point Likert scale ranging from 0 not at all confident to 6 completely cinfident Previous studies illustrated the test-rest reliability coefficient of PSEQ was 075 and internal consistency Cronbachs alpha was 095 which was reliable
Satisfaction and acceptability Participants satisfaction and acceptability of the dyadic intervention will be assessed at the end of the grogram Some open-ended questions will be asked including What topics content or concepts could have been covered in moreless detail As a result of participating in dyadic pain management intervention did you make some positive changes in your life Would you feel the group discussions interesting and informative Did the activities and exercises relieve your pain symptom These questions were used in previous studies to evaluate the satisfaction and acceptability of intervention program
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
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
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 medicalsurgical treatment in two months or have joined in other pain management program
4 Experience a drug addiction problem
Informal caregivers Inclusion criteria 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 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 medicalsurgical treatment in two months or have joined in other pain management program
4 Experience a drug addiction problem
Outcome measures It is a dyadic intervention so outcomes will be measured from older adults and informal caregivers
Primary outcome The Brief Pain Inventory-Chinese Version It is a tool to evaluate the intensity site quality relief interference and causes of pain in patients Four items for the degree of pain severity one item for the degree of pain relief and seven items for degree of pain interferes will assess numbering the different pain sites from 0 to 10 For BPI-C the Cronbachs α for the pain severity and pain interference items are 083-089 and 090-091 and has good acceptable test-retest reliability
Secondary outcomes
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 Previous studies showed that WHOQOL-BRIF has good internal consistency and validity
Depression Anxiety Stress Scale It is a self-administered psychological instrument to evaluate the degree of depression anxiety and stress involving 21 items Every part has seven items on a 4-point Likert scale ranging from 0 to 3 The instrument was used in previous studies and had good internal consistency and validity
Pain Self-efficacy Questionnaire It is a tool to measure the self-efficacy in coping with daily activities with pain A Chinese version of the PSEQ will be used in this study Participants will express participants confidence in performing ten activities experiencing pain on a 7-point Likert scale ranging from 0 not at all confident to 6 completely cinfident Previous studies illustrated the test-rest reliability coefficient of PSEQ was 075 and internal consistency Cronbachs alpha was 095 which was reliable
Satisfaction and acceptability Participants satisfaction and acceptability of the dyadic intervention will be assessed at the end of the grogram Some open-ended questions will be asked including What topics content or concepts could have been covered in moreless detail As a result of participating in dyadic pain management intervention did you make some positive changes in your life Would you feel the group discussions interesting and informative Did the activities and exercises relieve your pain symptom These questions were used in previous studies to evaluate the satisfaction and acceptability of intervention program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None