Telephone-based behaviour-therapeutic intervention to reduce family caregiver burden in chronic stroke (Telefongestützte verhaltenstherapeutische Intervention zur entlastung Pflegender angehöriger von Schlaganfall-betroffenen)

ISRCTN	ISRCTN86289718
DOI	https://doi.org/10.1186/ISRCTN86289718
Protocol serial number	328/2006V
Sponsor	Robert Bosch Hospital (Robert-Bosch-Krankenhaus) (Germany)
Funders	Central Associations of the Statutory Health Insurances (Spitzenverbaende der Pflegekassen), represented by the Federation of Salaried Employees Health Insurance Funds (Verband der Angestellten-Krankenkasse e.V.) (Germany), Added 20/07/09: Central National Association of the Statutory Health Insurance Funds (GKV-Spitzenverband) (Germany) since 01/07/2008

Submission date: 05/04/2007
Registration date: 22/06/2007
Last edited: 11/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin Hautzinger
Scientific

Abteilung für Klinische Psychologie und Entwicklungspsychologie
Universität Tübingen
Christophstr. 2
Tübingen
72072
Germany

Email	hautzinger@uni-tuebingen.de

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Telephone-based behaviour-therapeutic intervention to reduce family caregiver burden in chronic stroke (Telefongestützte verhaltenstherapeutische Intervention zur entlastung Pflegender angehöriger von Schlaganfall-betroffenen)
Study acronym	TIPS
Study objectives	A telephone-based behaviour-therapeutic intervention for family caregivers in chronic stroke can reduce their subjective caregiver burden and depressive symptoms. It does not raise total costs of formal and informal care or indirect costs.
Ethics approval(s)	The ethics committee of the University of Tuebingen (Germany) (www.uni-tuebingen.de), gave a positive vote for the study on the 25th October 2006 (ref: 328/2006V).
Health condition(s) or problem(s) studied	Burden of family caregivers of chronic stroke survivors
Intervention	Intervention group: Telephone-based problem solving training over 12 months. It comprises two home visits (after randomisation and month three) and regular telephone contacts with decreasing frequency over 12 months: 1. Month one: weekly 2. Months two to three: biweekly 3. Months 4 to 12: monthly, plus up to four additional optional contacts The problem solving procedure is structured into the following six steps using different cognitive-behavioural techniques like cognitive restructuring and communication skill training according to a fixed intervention manual: 1. Problem definition and facts 2. Optimism and orientation 3. Goal setting 4. Generation of alternatives 5. Decision making 6. Implementation and verification For initial problem orientation a card sorting procedure with 40 cards is used. The intervention is delivered by a psychologist. Intervention and control group: All participants receive a monthly information letter by post on care-giving or stroke related issues (i.e., caregiver rights, nutrition, relaxation techniques) over one year. Interventions and assessments are delivered by different teams; the assessment team is blinded to the different groups by the study centre. Because communicating of their status by the participants a complete blinding is probably not possible.
Intervention type	Other
Primary outcome measure(s)	1. Subjective caregiver burden (Sense of Competence Questionnaire [SCQ]) 2. Caregiver depression (the Centre for Epidemiological Studies Depression scale [CES-D]) 3. Total costs of formal and informal care 4. Indirect costs Measured at: T0 (Agreement) primary and secondary outcomes T1 (3 ½ months after T0) primary and secondary outcomes T2 (12 months after T0) primary and secondary outcomes T3 (24 months after T0) and T4 (36 months after T0) institutionalisation rates
Key secondary outcome measure(s)	1. Ability of social problem solving 2. Social activities 3. Social support 4. Subjective physical symptoms 5. Burden of behavioural symptoms 6. Subjective health related quality of life 7. Qualitative analysis of caregiver burden with description of main problem areas with the card set 8. Institutionalisation rates of care recipients over a prolonged observational period Measured at: T0 (Agreement) primary and secondary outcomes T1 (3 ½ months after T0) primary and secondary outcomes T2 (12 months after T0) primary and secondary outcomes T3 (24 months after T0) and T4 (36 months after T0) institutionalisation rates
Completion date	31/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	104
Total final enrolment	122
Key inclusion criteria	Care recipient: 1. 60 years or older at the time moment of index stroke* (loss of neurological function due to an ischaemic or haemorrhagic intracranial vascular event) 2. Formal need of care or help for at least 1.5 hours a day (10.5 hours per week) (this time criteria corresponds to the criteria for receiving benefits from the statutory German nursing insurance), or 3. Need of care in form of supervision or for care recipients with cognitive impairment for at least 1.5 hours a day (10.5 hours per week) (these people are currently not adequately considered by the statutory German nursing insurance, but might be in the future) Caregiver: 1. Age: 18 years and older 2. Family member, who has cared for the stroke survivor for at least six months 3. Time spent with care of stroke survivor (including nursing care, supervision and contact) at least 1.5 hours per day or 10.5 hours per week. There can be additional support with care (e.g. professional community nurses) 4. Significant caregiver burden assessed with six screening questions 5. Living in the region of Stuttgart (maximum of one hour with public transport from the study centre) 6. Availability of a telephone extension 7. At enrolment, plan to remain in area for the duration of the intervention 8. Ability to communicate over the telephone * In the case of recurring strokes the index stroke is defined as the last stroke that increases the demand of care in a significant way
Key exclusion criteria	Care recipient: 1. Planned nursing home placement within the next six months 2. Unstable or progressive severe disease 3. Terminal status based on a prognosis of less than six months Caregiver: 1. Duration of caregiving for the stroke survivor more than five years after index stroke 2. Mental disease like schizophrenia, alcohol addiction or cognitive impairment (rapid dementia screening test less than nine points) 3. Severe and unstable or progressive diseases like cancer 4. Not able to understand and speak German language 5. Temporary increased caregiver burden because of an acute illness (greater than repetition of the screening after such an episode of increased burden) 6. Involved in another clinical trial of interventions for caregivers (non-drug study)
Date of first enrolment	01/03/2007
Date of final enrolment	31/10/2010

Locations

Countries of recruitment

Germany

Study participating centre

Abteilung für Klinische Psychologie und Entwicklungspsychologie

Tübingen
72072
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2014	11/07/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/07/2019: Publication reference and total final enrolment added.