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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\u00a0interventions 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods\/ design<\/jats:title>\n                <jats:p>A pragmatic randomised controlled trial with 572 caregivers of older adults (\u2265 60\u2009years) receiving benefits of one of the two participating long-term care insurances. Participants are assigned (t<jats:sub>0<\/jats:sub>) to either the ReDiCare intervention or a control group receiving routine care and counselling. Data are collected at baseline (-t<jats:sub>1<\/jats:sub>), 3-month (t<jats:sub>1<\/jats:sub>), 9-month (t<jats:sub>2<\/jats:sub>) and 15-month (t<jats:sub>3<\/jats:sub>). The 9-month post-intervention assessment (t<jats:sub>2<\/jats:sub>) 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Deutsches Register Klinischer Studien (German Clinical Trials Register), <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/apps.who.int\/trialsearch\/Trial2.aspx?TrialID=DRKS00014593\">DRKS00014593<\/jats:ext-link> (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.drks.de\">www.drks.de,\u00a0<\/jats:ext-link>registered 14 May 2018) and International Clinical Trials Registry Platform, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/apps.who.int\/trialsearch\/Trial2.aspx?TrialID=DRKS00014593\">DRKS00014593\u00a0<\/jats:ext-link> (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/apps.who.int\/trialsearch\/\">https:\/\/apps.who.int\/trialsearch\/<\/jats:ext-link>).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12877-020-01941-w","type":"journal-article","created":{"date-parts":[[2021,1,6]],"date-time":"2021-01-06T17:13:16Z","timestamp":1609953196000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6486-4287","authenticated-orcid":false,"given":"Klaus","family":"Pfeiffer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Theurer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gisela","family":"B\u00fcchele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Babac","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helene","family":"Dick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Wilz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ReDiCare study group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Heidenreich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Astrid","family":"Elsbernd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Reuter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Ernst","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"Wollensak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dietrich","family":"Rothenbacher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Diepold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianna","family":"Hanke-Ebersoll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Daufratshofer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annabella","family":"Gottswinter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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All participants receive information leaflets and give written informed consent. Approval for the informed consent materials was received by the ethics committee.Data security officers of the participating long-term care insurances (AOK Bavaria, AOK Baden-W\u00fcrttemberg), the University of Jena, and the Robert-Bosch-Hospital as well as the two ministries for social affairs of the two involved states agreed to the data management and security protocol as well as to the participant information and consent form.All protocol modifications are communicated with the ethics committee, auditor, and trial registry. Modifications in the data management and security protocol are also communicated with the involved institutions.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All authors declare: no support from any organisation for the submitted work, other than funding arrangements for the trial described in body of the text; no financial relationships with any organisations or activities that could appear to have influenced the submitted work. AB is employed at the health and long-term care insurance AOK Bayern (AOK Bavaria) and temporary funded by the trial budget. Financial activities outside the submitted work: KP and GW has received fees (2018\u20132020) for the development of an online coach for family caregivers of the AOK Bundesverband (Federal Association of Local Health Insurance Funds). KP has also received fees for care counsellor trainings by long-term care insurances not involved in this study, care centres (\u201cPflegest\u00fctzpunkte\u201d), and other organisations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"4"}}