- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717077
Learned Resourcefulness Intervention
January 27, 2021 updated by: Chang Gung Memorial Hospital
Effect of Learned Resourcefulness Intervention on Learned Resourcefulness, Caregiver Burden, Quality of Life for Older Family Caregivers
This study aimed to test the effects of a learned resourcefulness interveniton program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A quasi-experimental trail will be used to test the effects of a learned resourcefulness intervention program on the learned resourcefulness, caregiver burden, quality of life for older family caregivers.
Through the use of convenience sampling strategy, one teaching medical hospital with approximately 104 older family caregivers in southern Taiwan will be recruited and simple randomly assigned based on teaching medical hospital to a Learned resourcefulness intervention program experimental group or a wait-list control group.
Participants in the experimental group will receive the learned resourcefulness intervention program led by researcher, one time per week, 50 minutes for one week, 10 minutes for these weeks; participants in the wait-list control group will continue to receive their home care service.
One pre-test and two post-tests, all participants will assessed for learned resourcefulness, caregiver burden, quality of life at baseline, and at 5 and 9 weeks of the study.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chiayi city, Taiwan, 61363
- Meng-Chun Chen (MCC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 60 and above
- family caregivers of disabled adults who received home care service
- cognitively intact as assessed by SPMSQ score of 8 and above
- disabled adults will assessed by Barthel Index score of 60 and bellow
- able to answer questions
Exclusion Criteria:
- participants with severe mental disabilities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Learned resourcefulness intervention
The learned resourcefulness program includes: 1) Solving problem strategy, 2) Organizing daily actions, 3) Using self-regulation, 4) Reframing positive situations, 5) Changing negative self-thinking, 6) Exploring new thinking and skills.
It is conducted one time per week.
|
The LR program includes: 1) Solving problem strategy, 2) Organizing daily actions, 3) Using self-regulation, 4) Reframing positive situations, 5) Changing negative self-thinking, 6) Exploring new thinking and skills.
It is conducted one time per week.
|
NO_INTERVENTION: Usual home care service
The control group maintains home care service
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-control as the learned resourcefulness measured by Rosenbaum's self control schedule
Time Frame: 9 weeks
|
which is a 36-item scale, is used to measure the cognitive and problem-solving skills, the higher the score, the better a self-control of a person
|
9 weeks
|
Caregiver burden measured by caregiver burden scale
Time Frame: 9 weeks
|
which is a 20-item scale by Lee and Wu, The total score ranges between 0 and 60, with a higher score representing a higher degree of burden.
|
9 weeks
|
Quality of life measured by EuroQol five dimension scale (ED-5Q)
Time Frame: 9 weeks
|
The EuroQol five dimension scale (ED-5Q) developed by the EuroQol Group, the higher the score, the better the state of health.
|
9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 6, 2019
Primary Completion (ACTUAL)
April 1, 2019
Study Completion (ACTUAL)
April 12, 2019
Study Registration Dates
First Submitted
October 22, 2018
First Submitted That Met QC Criteria
October 22, 2018
First Posted (ACTUAL)
October 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 27, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201801443B0C501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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