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Effectiveness of the problem-solving approach program toward caregiving burden and self- efficacy for elderly family caregivers of elderly patients with chronic disease
Last registered on August 13, 2019

Pre-Trial

Trial Information
General Information
Title
Effectiveness of the problem-solving approach program toward caregiving burden and self- efficacy for elderly family caregivers of elderly patients with chronic disease
RCT ID
AEARCTR-0004534
Initial registration date
August 12, 2019
Last updated
August 13, 2019 5:16 PM EDT
Location(s)

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Primary Investigator
Affiliation
Kanazawa University
Other Primary Investigator(s)
Additional Trial Information
Status
In development
Start date
2019-08-16
End date
2020-02-15
Secondary IDs
Abstract
Aim: To examine effectiveness of the problem-solving approach program toward caregiving burden and self- efficacy for elderly family caregivers of elderly patients with chronic disease. Hypotheses: 1) Caregiving burden will be reduced; caregiver’s abilities of coping to problems will be increased; and caregiver’s self-efficacy will be improved if the problem-solving approach is conducted to the family caregivers; 2) those positive conditions will be kept if this program including in regular free phone call support is conducted.
Overview: Study design is a non-invasive intervention study, using an education program, involving in one intervention group and two control groups which are a without free phone call support group and a usual care group. This study will be conducted in Viet Tiep Hospital in Haiphong city, Vietnam. Participants: We will recruit participants who are primary family caregivers of patients who have chronic diseases and will discharge to their home soon. Both participants and patients are 60≤ years old. The number of participants are ≤25 in each group. The participants will be randomly assigned to an intervention or control group by using a random numbers table. Methods: The program consists of the problem orientation (counselling to improve positive emotion) and the problem-solving skill training in order to reduce caregiving burden and to improve their self-efficacy, in addition to improve caregiving knowledge and skills, and the free phone call support in order to maintain the effectiveness. Education is provided to participants at their convenient time during patients’ hospitalization. Free phone call service is provided after patients’ discharge. Intervention period is total six months. Three nurse researchers (two as assistant researchers) intervene for the caregivers. Correspondence table is prepared, which is kept separated with data. Measurement: Face to face interview with a set of questionnaire with only research ID number is adapted to collect data about demographic characteristics, degree of caregiving burden, self-efficacy, coping status, and so on. Baseline data will be collected at participants’ convenient time during patients’ hospitalization; when participants come to outpatient, outcome and follow-up data will be collected during patients are taking medical tests. Two research assistants who are working in the hospital as clinical nurses collect data for baseline and outcome. We do not use hospital records. Data are analyzed statistically. Findings will be presented in conferences and be published in an academic journal without personal information. Research related information are kept strictly.
Significance: This program is expected to reduce caregiving burden and to increase caregiver’s self-efficacy, which will contribute to prevent elderly caregivers from depression resulted from caregiving activities and to provide better quality of life. In addition, we expect that elderly patients can have better care without any abuse, resulting in they also have better quality of life, since this program involves education about caregiving technique and coping strategy for elderly caregivers.
External Link(s)
Registration Citation
Citation
Pham, Thi Thu Huong. 2019. "Effectiveness of the problem-solving approach program toward caregiving burden and self- efficacy for elderly family caregivers of elderly patients with chronic disease." AEA RCT Registry. August 13. https://doi.org/10.1257/rct.4534-1.0.
Former Citation
Pham, Thi Thu Huong. 2019. "Effectiveness of the problem-solving approach program toward caregiving burden and self- efficacy for elderly family caregivers of elderly patients with chronic disease." AEA RCT Registry. August 13. https://www.socialscienceregistry.org/trials/4534/history/51695.
Experimental Details
Interventions
Intervention(s)
A randomized control trial research will be performed
Intervention Start Date
2019-08-20
Intervention End Date
2020-02-15
Primary Outcomes
Primary Outcomes (end points)
Examination for reducing caregiving burden via Zarit Burden Interview scale.
Primary Outcomes (explanation)
Examination for improvement of self-efficacy, coping skills, and problem-solving abilities via ‘Revised Scale for Caregiving Self-efficacy’ ‘Brief COPE (PTLDS) scale’ ‘Problem-Solving Inventory’
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Study design is a non-invasive intervention study, involving in one intervention group and two control groups. 1) The intervention group will be provided a family caregiver problem-solving program including in the ADL assistance training and regular free phone call for maintenance of the effectiveness (FCPSM group); 2) One of the control group will be provided a family caregiver problem-solving program including in the ADL assistance training without regular free phone call (FCPS group); 3) The other control group will be conducted a usual care (Usual care group). The total intervention period is six months.
Experimental Design Details
Not available
Randomization Method
randomization done in office by a computer
Randomization Unit
individual randomization
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
3 groups
Sample size: planned number of observations
75 family caregivers
Sample size (or number of clusters) by treatment arms
25 family caregivers
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
90 %
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
IRB Approval Date
IRB Approval Number