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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00014593 |
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Date of registration:
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14/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Relieving Distressed Caregivers: A Pragmatic Trial.
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Scientific title:
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Relieving Distressed Caregivers: A Pragmatic Trial. - ReDiCare |
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Date of first enrolment:
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15/05/2018 |
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Target sample size:
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504 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00014593 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: Other; Assignment: parallel; Study design purpose: other
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Phase:
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3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Gabriele
Wilz |
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Address:
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Humboldtstraße 11
07743
Jena
Germany |
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Telephone:
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++49 (0)3641-945170 |
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Email:
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berta@uni-jena.de |
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Affiliation:
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Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung für Klinisch-Psychologische Intervention |
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Name:
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Gabriele
Wilz |
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Address:
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Humboldtstraße 11
07743
Jena
Germany |
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Telephone:
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++49 (0)3641-945170 |
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Email:
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berta@uni-jena.de |
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Affiliation:
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Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung für Klinisch-Psychologische Intervention |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria regarding care recipient:
a) 60 years or older
b) Level of care (German "Pflegegrad") 1-5
c) Member of AOK long-term care insurance
For caregiver:
a) 18 years or older
b) Provides care, support or supervision (including travel time) for the care recipient for at least 1.5 hours per day or at least 10.5 hours per week
c) Has telephone access
d) Is able to communicate via telephone
e) Positive screening if two out of three questions regarding high level of burden answered with yes ((1) Care-related physical or mental health problems, (2) Loneliness, (3) Burden of care).
Exclusion criteria: Exclusion criteria regarding care recipient:
a) Lives in a nursing home
b) Plans to move to a nursing home within the next three months
c) Palliative care
d) Terminal disease (life expectancy < 6 months)
For caregiver:
a) Received care counseling (incl. provision plan) within the last six months
b) Severe unstable or progressive disease
c) Insufficient German language skills
d) Currently receiving psychotherapy
e) Enrollment in another study for caregivers and / or with psychosocial/psychotherapeutic intervention
f) Severe psychiatric diagnosis
g) Apparent cognitive impairments
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Burden of care
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Intervention(s)
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Group 1: Intervention group:
Participants in the intervention group receive a stepped intervention over 9 months and monthly information letters with care specific information throughout the intervention period.
Intervention period 1: Participants receive care counseling over 3 months delivered by a care counselor from the long-term care insurance of the care recipient. Counseling consists of at least one home visit (Bavaria) [02.11.2020: in line with the changing COVID-19 restrictions and official instructions the following alternative settings for the initial contact are allowed: face-to-face contact in the service center of the long-term care insurance or telephone-based initial contact] / initial telephone call (Baden-Wuerttemberg) including an assessment and at least 2 additional follow-up telephone calls. The intervention method is based on problem-solving and provides caregivers with professional advice on all questions about long-term care insurance and available services (in line with the statutory care counseling / social act §7a SGB XI). The offered care counseling aims particulary to improve problem-focused coping in caregiver’s everyday life. Care counselors have been trained in the problem-solving approach prior to the intervention period in a 2-day workshop, as well as in 1 follow-up training day and are continuously coached by licensed psychotherapists during the intervention. The coaching primarily aims to monitor treatment fidelity as well as to support counselors in coping with difficult counseling situations and other work-related stressors.
Intervention period 2: After completion of intervention period 1, the care counselor screens the caregiver for persisting high burden and difficulties in providing or organizing care. Depending on the outcome o
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Primary Outcome(s)
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Depressive symptoms (Center for Epidemiological Studies Depression Scale (CES-D) measured at all 4 time points
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Secondary Outcome(s)
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- Physical complaints (Gießener Beschwerdebogen (GBB; Brähler, Hinz, & Scheer, 2008))
- Health-related quality of life (Veterans Rand 12 (VR-12; Kazis et al., 2004; Buchholz & Kohlmann, 2015)
- Utilization of psychosocial resources (2 adapted scales from “the Psychosocial Resource Utilization Questionnaire” (Trösken & Grawe, 2003): Utilization of resources related to well-being (9 items), utilization of resources related to coping with daily hassles (14 items; Töpfer, Sengewald, & Wilz, in prep., Töpfer & Wilz, subm.)
- Emotional well-being (visual analogue scale; Wilz & Soellner, 2016)
- Self-efficacy (Abbreviated Sense of Competence Questionnaire; Pendergrass et al., 2015; subscales "satisfaction with one's own performance", "consequences of involvement in care for the caregiver's life")
- Coping with problems (Social problem-solving inventory - revised (SPSI-R; D'Zurilla, Nezu, & Maydeu-Olivares, 2002; Graf, 2003; subscale "negative problem orientation")
- Quality of relationships (1 question)
- "Coping with the care situation" (1 question)
- Positive aspects of caregiving (6 questions)
- Perceived quality of care (care (14 questions), abusive behavior (8 questions))
- Health economic evaluation
Assessments are measured at all 4 time points
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Source(s) of Monetary Support
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Bundesministerium für Bildung und Forschung (BMBF) Förderzeichen: 01GL1702(A-C)
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Ethics review
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Status: Approved
Approval date: 06/03/2018
Contact:
ethikzentrum@uni-jena.de
Ethikkommission der Fakultät für Sozial- und Verhaltenswissenschaften [Friedrich-Schiller-Universität Jena
Ethikkommission der Fakultät für Sozial- und Verhaltenswissenschaften]
+49 (0) 3641 / 9 45 800
ethikzentrum@uni-jena.de
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