Condition category
Mental and Behavioural Disorders
Date applied
30/12/2013
Date assigned
27/01/2014
Last edited
14/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Klaus Pfeiffer

ORCID ID

Contact details

Robert-Bosch-Hospital (Robert-Bosch-Krankenhaus)
Department of Clinical Gerontology and Rehabilitation (Klinik für Geriatrische Rehabilitation)
Auerbachstr. 110
Stuttgart
70376
Germany
+49 (0)711 8101 2232
klaus.pfeiffer@rbk.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

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)

Study information

Scientific title

Problem-solving in caregiver counseling: a cluster randomized implementation study

Acronym

PLiP (ProblemLösen in der Pflegeberatung)

Study hypothesis

An 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

The Ethics Committee of the University of Tuebingen, Germany, 17/10/2013, ref.: 508/2013BO2

Study design

An implementation study with a prospective cluster randomized, wait-list controlled design

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Depressive symptoms of informal family caregivers

Intervention

The 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Informal 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 measures

Informal 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 trial start date

15/11/2013

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Caregiver 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44 randomized caregiver counselors. Consecutive recruitment of 6 caregivers for evaluation by each counselor (n = 264).

Participant exclusion criteria

Caregiver 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

Recruitment start date

15/11/2013

Recruitment end date

29/02/2016

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

Reinhardtstr. 30
Berlin
10117
Germany
-
info@gkv-spitzenverband.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.