Contact information
Type
Scientific
Primary contact
Prof Martin Hautzinger
ORCID ID
Contact details
Abteilung für Klinische Psychologie und Entwicklungspsychologie
Universität Tübingen
Christophstr. 2
Tübingen
72072
Germany
hautzinger@uni-tuebingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
328/2006V
Study information
Scientific title
Acronym
TIPS
Study hypothesis
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
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).
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/03/2007
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
104 participants after 12 months
Participant 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)
Recruitment start date
01/03/2007
Recruitment end date
31/10/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Abteilung für Klinische Psychologie und Entwicklungspsychologie
Tübingen
72072
Germany
Sponsor information
Organisation
Robert Bosch Hospital (Robert-Bosch-Krankenhaus) (Germany)
Sponsor details
c/o Klaus Pfeiffer
Geriatrisches Kompetenzzentrum
Robert-Bosch-Krankenhaus
Auerbachstr. 110
Stuttgart
70376
Germany
klaus.pfeiffer@rbk.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added 20/07/09: Central National Association of the Statutory Health Insurance Funds (GKV-Spitzenverband) (Germany) since 01/07/2008
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