ISRCTN ISRCTN23635523
DOI https://doi.org/10.1186/ISRCTN23635523
Secondary identifying numbers Pilot projects for further development of the statutory German nursing care insurance according to § 8 Abs. 3 SGB XI (Modellvorhaben zur Weiterentwicklung der Pflegeversicherung gem. § 8 Abs.3 SGB XI)
Submission date
30/12/2013
Registration date
27/01/2014
Last edited
08/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study is based on results of a previous study with family caregivers (ISRCTN86289718 - http://www.isrctn.com/ISRCTN86289718). The aim of this study is to train caregiver counselors in structured problem-solving (PS) and to evaluate its effectiveness in routine settings.

Who can participate?
Caregiver counselors, and family caregivers (age >18) who are assigned to one of the participating counselors and experience significant burden (physical and mental health, loneliness).

What does the study involve?
Counselors are randomly allocated to the training group or the waiting list group.
Counselors allocated to the training group receive training in problem solving (PS). It focuses on using PS for caregiver issues or problems, to master possible challenging interactions with the caregiver during counseling, and to overcome work-related difficulties. The training is delivered in a workshop (two days and one follow-up day) plus bi-weekly individual supervision by a psychotherapist over six months. Caregiver counselors are evaluated before and after training, and six months later. The counselors of the waiting list group counsel or give advice to caregivers according to standard home care counseling.
Caregivers receive regular counseling by one of the participating counselors with or without advanced PS training. Caregivers' depressive symptoms and further outcomes like caregiver self-efficacy, leisure time satisfaction and negative problem-orientation are assessed after enrolment, and after three and six months. A random sample of participating caregivers is interviewed in addition to the assessments.

What are the possible benefits and risks of participating?
We hope there is a positive impact on both sides: the caregivers who receive better help by the trained counselors, and the trained counselors who can improve their qualification. All participating counselors will eventually receive the advanced training. We do not expect any risks for counselors and caregivers taking part in this study.

Where is the study run from?
1. Clinic for Geriatric Rehabilitation, Robert-Bosch-Hospital (Germany)
2. Department of Clinical Psychology and Psychotherapy of the University of Tübingen (Germany)

When is the study starting and how long is it expected to run for?
Training and evaluation are running from November 2013 to October 2016

Who is funding the study?
The study is funded by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), Germany.

Who is the main contact?
Dr Klaus Pfeiffer
klaus.pfeiffer@rbk.de

Contact information

Dr Klaus Pfeiffer
Scientific

Robert-Bosch-Hospital (Robert-Bosch-Krankenhaus)
Department of Clinical Gerontology and Rehabilitation (Klinik für Geriatrische Rehabilitation)
Auerbachstr. 110
Stuttgart
70376
Germany

Phone +49 (0)711 8101 2232
Email klaus.pfeiffer@rbk.de

Study information

Study designAn implementation study with a prospective cluster randomized, wait-list controlled design
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleProblem-solving in caregiver counseling: a cluster randomized implementation study
Study acronymPLiP (ProblemLösen in der Pflegeberatung)
Study objectivesAn advanced training in problem-solving for caregiver counselors has a positive impact on family caregivers who experience burden and depressive symptoms compared to usual counseling according to the German social legislation 7a SGB XI.
Ethics approval(s)The Ethics Committee of the University of Tuebingen, Germany, 17/10/2013, ref.: 508/2013BO2
Health condition(s) or problem(s) studiedDepressive symptoms of informal family caregivers
InterventionThe counselors randomized to the training condition receive a specific training over six months. The counselor training is based on problem-solving (PS) for caregiver counselors according to the six principles of the problem-solving model developed by D'Zurilla and colleagues (D'Zurilla & Goldfried, 1971; D'Zurilla, Nezu, & Maydeu-Olivares, 2004; D'Zurilla & Nezu, 2006): (a) optimism and orientation, (b) problem definition and facts, (c) goal setting, (d) generation of alternatives, (e) decision making, and (f) implementation and verification. The training in PS comprises the following three dimensions: (1) facilitating caregiver PS with the structured PS approach, a card-sorting task that was developed to identify problems unique to each caregiver, and tailored written information, (2) using PS to master difficult or challenging interactions with the caregiver, (3) using PS for own work-related difficulties as an aspect of mental hygiene.

The training is delivered in an initial two-day workshop, a follow-up day after 4 months, and individual bi-weekly telephone supervision contacts over six months after the initial workshop to facilitate the implementation of the PS principles and the card-sorting task in daily counseling practice. During the evaluation period (over a further 6 months) after the training period the counselors have four additional contacts with their supervisor.

The trainers and supervisors are cognitive behavioral therapists and clinical psychologists with specific experience in PS training with caregivers.

The counselors of the control condition (waiting-list control group) counsel or give advice to caregivers according to the statutory home care counseling (7a SGB XI).

The project is evaluated on two different levels: impact of the caregiver counseling 1) on the informal caregivers (main endpoint, telephone interviews), and 2) on the caregiver counselor (paper-and-pencil interviews).

Evaluation:
Prof. Dr. Martin Hautzinger
Clinical Psychology and Psychotherapy
University of Tuebingen
(Abteilung für Klinische Psychologie und Entwicklungspsychologie - Universität Tübingen)
Schleichstr. 4
72076 Tübingen
Germany
Email: hautzinger@uni-tuebingen.de

Randomisation:
Ulm University - Institute of Epidemiology and Medical Biometry
Intervention typeOther
Primary outcome measureInformal caregiver:
Depressive symptoms (Centre for Epidemiological Studies Depression scale; Radloff, 1977). Measured at T0 (after enrollment) , T1 (3 months after T0), T2 (6 months after T0)
Secondary outcome measuresInformal caregiver:
1. Caregiver burden (Sense of Competence Questionnaire; Vernooij-Dassen,1993) - Short version (Pendergrass et al., submitted).
2. Subjective physical complaints (Giessen Subjective Complaints List [Gießener Beschwerdebogen]; Brähler, Hinz & Scheer, 2008) - Subscale: Pains in Limbs (updated 21/07/2015; was previously Exhaustion).
3. Negative problem orientation (Social Problem Solving Inventory - Revised; D'Zurilla, Nezu, & Maydeu-Olivares, 2002; Graf, 2003) - Subscale: Negative Problem Orientation.
4. Leisure time satisfaction (Leisure Time Satisfaction Questionnaire, Stevens et al., 2004).

Additional assessments:
1. Health service use (3 months retrospective)
2. Care-related quality of life (CarerQol; Brouwer, et al., 2006)
3. Semi-structured interviews with a random sample of caregivers

All caregiver domains (except the interviews) are measured at:
T0 (after enrollment)
T1 (3 months after T0)
T2 (6 months after T0)

Caregiver counselor:
1. Session management self-efficacy (Counselor Activity Self-Efficacy Scales; Lent et al., 2003) - Subscale: Session Management Self-Efficacy.
2. Difficult client behaviors self-efficacy (Counseling Self-Estimate Inventory; Larson et al., 1992) - Subscale: Difficult Client Behaviors.

Additional assessments:
1. Burnout (Maslach Burnout Inventory; Büssing et al., 1992) - Subscales: Emotional Exhaustion, Depersonalization, and Personal Accomplishment.
2. Self-Care (Program to promote psychosocial health resources; Kaluza, 2011) - Subscale: Self-Care Questionnaire.
3. Evaluation questionnaire by the informal caregiver.
4. Workload (Trier Inventory of Chronic Stress; Schulz, Schlotz & Becker 2004) - Subscale: Workload.
Counselors assigned to the intervention group are evaluated at T0 (enrollment, previous to the training), 6 months after T0 (after the training), 12 months after T0 (after the caregiver evaluation period).

Counselors assigned to the waiting list are evaluated at T0 (enrollment), 6 months after T0 (after the caregiver evaluation period; previous to the training), 12 months after T0 (after the training).
Overall study start date15/11/2013
Completion date31/10/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants44 randomized caregiver counselors. Consecutive recruitment of 6 caregivers for evaluation by each counselor (n = 264).
Key inclusion criteriaCaregiver counselors:
1. Providing caregiver counseling according to 7a SGB XI
2. Are qualified according to the recommendations of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband)
3. Agreed to participate in the advanced training 'Family caregiver counseling is problem-solving' and the evaluation.

Informal caregivers:
1. Significant subjective caregiver burden assessed with three screening questions (decreased mental and physical health, feelings of loneliness, subjective caregiver burden)
2. Comprehensive counseling or case management is necessary (at least one personal counseling session and at least one telephone-based or personal follow-up contact)
3. Having the primary responsibility for someone who cannot fully take care of himself or herself according to the criteria of the German statutory nursing insurance
4. Is the main contact person for the caregiver counselor
5. 18 years and older
6. Consented to participate in the evaluation
Key exclusion criteriaCaregiver counselors:
1. Incomplete participation in the advanced training course 'Family caregiver counseling is problem-solving' (non-participation in the 2-day main training course or/and less than 50% of the 13 bi-weekly supervision telephone contacts)

Informal caregivers:
1. Professional paid responsibility for care recipient
2. Not able to speak and read German
Date of first enrolment15/11/2013
Date of final enrolment29/02/2016

Locations

Countries of recruitment

  • Germany

Study participating centre

Robert-Bosch-Hospital (Robert-Bosch-Krankenhaus)
Auerbachstraße 110
Stuttgart
70376
Germany

Sponsor information

National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) (Germany)
Hospital/treatment centre

Reinhardtstr. 30
Berlin
10117
Germany

Email info@gkv-spitzenverband.de
ROR logo "ROR" https://ror.org/03psr2094

Funders

Funder type

Industry

The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 06/03/2017 Yes No

Editorial Notes

08/03/2017: Publication reference added.
14/01/2016: The overall trial end date has been updated from 30/04/2016 to 31/10/2016. The recruitment end date has also been updated from 30/04/2016 to 29/02/2016.