Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial

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/).

Effects of general change mechanisms on outcome in telephone‐based cognitive‐behavioral therapy for distressed family caregivers

“…The current study is based on data from a pragmatic randomized controlled trial conducted in Germany which was designed to evaluate the effectiveness of a stepped care approach for burdened caregivers (Pfeiffer et al, 2021). Participants were recruited by employees of two participating German long‐term care insurances.…”

When Sons and Daughters Care for a Parent

“…This study is based on baseline data from the ReDiCare project, a randomized controlled trial with caregivers of older adults receiving benefits from a participating German long-term care insurance (Pfeiffer et al, 2021). Among other eligibility criteria, the caregivers had to provide care and assistance in IADLs, ADLs, or supervision for at least 1.5 hours per day on average or 10.5 hours per week (including travel time) and report distress associated with caregiving.…”

“…Among other eligibility criteria, the caregivers had to provide care and assistance in IADLs, ADLs, or supervision for at least 1.5 hours per day on average or 10.5 hours per week (including travel time) and report distress associated with caregiving. The care recipient had to be 60 years or older and categorized into a care degree ("Pflegegrad") from 1 to 5, indicating the degree of self-reliance restrictions according to the German Long-Term Care Act (Pfeiffer et al, 2021). For further information on sampling strategy, refer to the study protocol of ReDiCare (Pfeiffer et al, 2021).…”

Belastungserleben pflegender Angehöriger während der Coronapandemie

“…Die vorliegende Befragung erfolgte als ergänzende Erhebung im Rahmen einer randomisierten kontrollierten Interventionsstudie zu einem gestuften Beratungsansatz für hochbelastete pflegende Angehörige [13]. Als Intervention wurde ein strukturiertes Problemlösen für pflegende Angehörige im Rahmen einer Pflegeberatung ( § 7 a SGB XI) mit einer nachfolgenden optionalen telefonischen psychotherapeutischen Unterstützung kombiniert und mit einer Kontrollgruppe (Regelversorgung) verglichen.…”

“…Rekrutiert wurden die Probanden über die kooperierenden Pflegekassen der Gepflegten. Die Ausschlusskriterien sowie ausführliche Informationen zur Hauptstudie können dem Studienprotokoll entnommen werden [13].…”