Self-ControlNCT03717077
Learned Resourcefulness Intervention
A study testing learned resourcefulness intervention in people with Self-Control and Caregiver Burden, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-Control, Caregiver Burden, Quality of Life
- What is being tested?
- learned resourcefulness intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jan 2019to 12 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- participants with severe mental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Self-Control, Caregiver Burden, Quality of Life
- Being tested
- learned resourcefulness intervention
- Medical subject headings
- Self-Control, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
learned resourcefulness interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Learned resourcefulness intervention | Experimental | 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. Receives: Procedure: learned resourcefulness intervention |
| Usual home care service | No intervention | The control group maintains home care service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-control as the learned resourcefulness measured by Rosenbaum's self control schedule
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
Measured: 9 weeks
Caregiver burden measured by caregiver burden scale
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.
Measured: 9 weeks
Quality of life measured by EuroQol five dimension scale (ED-5Q)
The EuroQol five dimension scale (ED-5Q) developed by the EuroQol Group, the higher the score, the better the state of health.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start6 Jan 2019
- Primary completion1 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717077
- Sponsor's protocol ID
- 201801443B0C501
- Status last verified
- Jan 2021
- First submitted
- 22 Oct 2018
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Learned Resourcefulness Intervention on Learned Resourcefulness, Caregiver Burden, Quality of Life for Older Family Caregivers
- ClinicalTrials.gov ID
- NCT03717077
- Acronym / sponsor ID
- 201801443B0C501
- Conditions
- Self-Control, Caregiver Burden, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learned resourcefulness intervention | Experimental | Procedure: learned resourcefulness interventionThe 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. |
| Usual home care service | No intervention | –The control group maintains home care service |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- participants with severe mental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| learned resourcefulness interventionThe 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. | Procedure or surgery | Learned resourcefulness intervention |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing learned resourcefulness intervention in people with Self-Control and Caregiver Burden, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-control as the learned resourcefulness measured by Rosenbaum's self control schedule (time frame: 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.