Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial
Authors: Pfeiffer Klaus , Theurer Christina , Büchele Gisela , Babac Ana , Dick Helene , Wilz Gabriele ,   the ReDiCare study group, Heidenreich Thomas , Elsbernd Astrid , Reuter Maja , Ernst Christian , Wollensak Tanja , Rothenbacher Dietrich , Diepold Maximilian , Hanke-Ebersoll Marianna , Daufratshofer Lisa , Gottswinter Annabella , Bavaria A. O. K. , Medina Maria Gonzalez , Baden-Wuerttemberg A. O. K. , Becker Clemens , Hauztinger Martin , Zank Susanne , Schäufele Martina , Oswald Frank , Jansen Sabine , Elliott Timothy 
Published: January 2021

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/).