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 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
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28264663