Klaus Pfeiffer1, Christina Theurer2, Gisela Büchele3, Ana Babac4, Helene Dick5, Gabriele Wilz2. 1. Department of Clinical Gerontology and Geriatric Rehabilitation, Robert-Bosch-Hospital, Stuttgart, Germany. klaus.pfeiffer@rbk.de. 2. Department of Counseling and Clinical Intervention, Friedrich Schiller University Jena, Institute of Psychology, Jena, Germany. 3. Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany. 4. AOK Bavaria, Munich, Germany. 5. Institute of Health Care and Public Management, University of Hohenheim, Stuttgart, Germany.
Abstract
BACKGROUND: Providing care for someone with a disease or chronic condition can have a negative psychological, physical, social, and economic impact upon informal caregivers. Despite the socio-economic relevance and more than three decades of caregiver intervention research only very few translational efforts of successful interventions are reported. Still less of these interventions have been implemented into routine services. The aim of the ReDiCare study (German acronym BerTA) is to evaluate the effectiveness of a stepped counselling approach for burdened caregivers delivered by care counsellors of two long-term care insurances and registered psychotherapists. METHODS/ DESIGN: A pragmatic randomised controlled trial with 572 caregivers of older adults (≥ 60 years) receiving benefits of one of the two participating long-term care insurances. Participants are assigned (t0) to either the ReDiCare intervention or a control group receiving routine care and counselling. Data are collected at baseline (-t1), 3-month (t1), 9-month (t2) and 15-month (t3). The 9-month post-intervention assessment (t2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. Depressive symptoms measured with the CES-D are the primary outcome. The main secondary outcomes are physical complaints, utilization of psychosocial resources, caregiver self-efficacy and burden, positive aspects of caregiving and perceived care quality. A process evaluation, including audio tapes, self-report questionnaires and documentation will be conducted to examine internal and external validity of the intervention. Data on direct and indirect costs are collected for the (health) economic evaluation, using a health care perspective and a societal perspective. DISCUSSION: While comparable previous caregiver interventions have been developed and evaluated for specific caregiver groups (e.g. dementia caregivers, stroke caregivers), the ReDiCare study will indicate whether a stepped approach will be effective also in a broader group of caregivers. The intervention is one of the very few translational studies in caregiver intervention research and will provide valuable insights into relevant factors for training, intervention protocol adherence, effectiveness, and costs for future implementation steps. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00014593 ( www.drks.de, registered 14 May 2018) and International Clinical Trials Registry Platform, DRKS00014593 ( https://apps.who.int/trialsearch/ ).
RCT Entities:
BACKGROUND: Providing care for someone with a disease or chronic condition can have a negative psychological, physical, social, and economic impact upon informal caregivers. Despite the socio-economic relevance and more than three decades of caregiver intervention research only very few translational efforts of successful interventions are reported. Still less of these interventions have been implemented into routine services. The aim of the ReDiCare study (German acronym BerTA) is to evaluate the effectiveness of a stepped counselling approach for burdened caregivers delivered by care counsellors of two long-term care insurances and registered psychotherapists. METHODS/ DESIGN: A pragmatic randomised controlled trial with 572 caregivers of older adults (≥ 60 years) receiving benefits of one of the two participating long-term care insurances. Participants are assigned (t0) to either the ReDiCare intervention or a control group receiving routine care and counselling. Data are collected at baseline (-t1), 3-month (t1), 9-month (t2) and 15-month (t3). The 9-month post-intervention assessment (t2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. Depressive symptoms measured with the CES-D are the primary outcome. The main secondary outcomes are physical complaints, utilization of psychosocial resources, caregiver self-efficacy and burden, positive aspects of caregiving and perceived care quality. A process evaluation, including audio tapes, self-report questionnaires and documentation will be conducted to examine internal and external validity of the intervention. Data on direct and indirect costs are collected for the (health) economic evaluation, using a health care perspective and a societal perspective. DISCUSSION: While comparable previous caregiver interventions have been developed and evaluated for specific caregiver groups (e.g. dementia caregivers, stroke caregivers), the ReDiCare study will indicate whether a stepped approach will be effective also in a broader group of caregivers. The intervention is one of the very few translational studies in caregiver intervention research and will provide valuable insights into relevant factors for training, intervention protocol adherence, effectiveness, and costs for future implementation steps. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00014593 ( www.drks.de, registered 14 May 2018) and International Clinical Trials Registry Platform, DRKS00014593 ( https://apps.who.int/trialsearch/ ).
Authors: Tammy C Hoffmann; Paul P Glasziou; Isabelle Boutron; Ruairidh Milne; Rafael Perera; David Moher; Douglas G Altman; Virginia Barbour; Helen Macdonald; Marie Johnston; Sarah E Lamb; Mary Dixon-Woods; Peter McCulloch; Jeremy C Wyatt; An-Wen Chan; Susan Michie Journal: BMJ Date: 2014-03-07
Authors: Klaus Pfeiffer; Martin Hautzinger; Margarete Patak; Julia Grünwald; Clemens Becker; Diana Albrecht Journal: BMC Geriatr Date: 2017-03-06 Impact factor: 3.921