Needs and demands of informal caregivers [Bedürfnisse und Bedarfe pflegender Angehöriger]
| ISRCTN | ISRCTN15128297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15128297 |
| Secondary identifying numbers | 20-220_3-B |
- Submission date
- 07/09/2023
- Registration date
- 02/10/2023
- Last edited
- 17/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Despite the various professional support services that already exist to reduce the burden on informal caregivers, the utilisation of these services is currently low. Apart from the care receivers´ fear of losing their independence, the lack of knowledge about existing services is a possible reason for the low utilisation of these services. In addition, it is essential that professional support services actually meet the needs of informal caregivers (e.g. which specific services are desired or needed by the informal caregivers and to what extent). Preliminary work shows that although there is a high need for various support services, the overall utilisation rate is low. In addition, it is still unclear which group of people specifically uses or can benefit from professional support services and which different needs (i.e. concrete expectations/wishes concerning support services, e.g. spiritual, emotional, etc) exist in informal care.
The overall aim of the study is to investigate the needs as well as the individual demands of informal caregivers who care for people suffering from different illnesses and different stages of illness in the form of a written survey (questionnaire) in all regions of the German federal state of Bavaria (Freistaat Bayern). In addition, some of the respondents will participate in a more in-depth investigation of aspects of their individual quality of life and spiritual needs using qualitative interviews. A second focus of the survey is to determine the reasons for the use or non-use of respite and support services for informal caregivers and their care receivers in Bavaria.
Who can participate?
The participants are adult informal caregivers in the German federal state of Bavaria (Freistaat Bayern) who submitted an initial application for a care degree or an application for an increase in the care degree for the person being cared for. During the precursor study ProCare (https://doi.org/10.1186/ISRCTN1339092), 25,000 persons were contacted by the care advisors of the Medizinischer Dienst Bayern (MD Bayern) in the course of an assessment interview from September to December 2022 and received the first questionnaire. Participants of the current study are all persons who filled out the first questionnaire and gave their consent for further questionnaires. Based on the authors' experience in previous studies, it is expected that about 6,000 of the 25,000 persons will fill out the first questionnaire and that approximately 1,500 will give informed consent for further questionnaires.
What does the study involve?
Based on the in-depth qualitative interviews and the quantitative longitudinal data, important insights into the Bavarian caregiver´s needs and demands will be provided. Furthermore, the researchers will determine what kind of professional support services have a positive effect on the home care situation, in particular on the informal caregivers. In summary with the findings on the reasons for non-use of care counselling and other support and respite services, strategies to improve their utilisation can be developed. This can make an essential contribution to strengthening home care for chronically ill people and to make it more future-proof. After all, informal caregivers will continue to be systemically relevant in the future. For this reason, measures should be taken now to encourage informal caregivers. This includes, quite essentially, that offers to mental and nursing respite are tailored to the needs and demands of family caregivers. Thus, an important contribution can be made to the future of home care in Bavaria.
What are the possible benefits and risks of participating?
Due to voluntary participation in the survey, there will be no risks. The researchers expect to generate empirical longitudinal data focusing on the needs and demands of informal caregivers to strengthen the home care situation in the German federal state of Bavaria (Freistaat Bayern).
Where is the study run from?
1. Centre for Health Services Research, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) (Germany)
2. Professur für Spiritual Care und psychosomatische Gesundheit, Klinikum rechts der Isar der Technischen Universität München (TUM) (Germany)
When is the study starting and how long is it expected to run for?
August 2022 to December 2024
Who is funding the study?
Bayerisches Staatsministerium für Gesundheit und Pflege (Germany)
Who is the main contact?
1. Dr Anna Pendergrass, anna.pendergrass@uk-erlangen.de
2. Prof. Dr Eckhard Frick, eckhard.frick@tum.de
3. Dr André Kratzer, andre.kratzer@uk-erlangen.de
4. Prof. Dr Elmar Graessel, elmar.graessel@uk-erlangen.de
Contact information
Principal Investigator
Centre for Health Services Research
Universitätsklinikum Erlangen
Friedrich-Alexander-Universität Erlangen-Nürnberg
Schwabachanlage 6
Erlangen
91054
Germany
 ORCID ID |
0000-0002-2492-0229 |
|---|---|
| Phone | +49 (0)9131 85-34142 |
| anna.pendergrass@uk-erlangen.de |
Principal Investigator
Centre for Health Services Research
Universitätsklinikum Erlangen
Friedrich-Alexander-Universität Erlangen-Nürnberg
Schwabachanlage 6
Erlangen
91054
Germany
| ORCID ID |
0000-0001-7906-3079 |
|---|---|
| Phone | +49 (0)9131 85-34142 |
| andre.kratzer@uk-erlangen.de |
Principal Investigator
Professur für Spiritual Care und psychosomatische Gesundheit
Klinikum rechts der Isar
Technische Universität München (TUM)
München
80539
Germany
| ORCID ID |
0000-0002-6753-1004 |
|---|---|
| Phone | +49 (0)89 23 86 22 30 |
| eckhard.frick@tum.de |
Scientific
Centre for Health Services Research
Universitätsklinikum Erlangen
Friedrich-Alexander-Universität Erlangen-Nürnberg
Schwabachanlage 6
Erlangen
91054
Germany
| Phone | +49 (0)9131 85-34142 |
|---|---|
| elmar.graessel@uk-erlangen.de |
Study information
| Study design | Observational multi-centre longitudinal study including two data collection points |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant informant sheet |
| Scientific title | Needs and demands of informal caregivers - Longitudinal study to strengthen home care in Bavaria [Bedürfnisse und Bedarfe pflegender Angehöriger - Längsschnittstudie zur Stärkung der häuslichen Pflege in Bayern] |
| Study objectives | To investigate the needs and individual demands of informal caregivers focusing on two research objectives: 1. Identifying reasons for the use or non-use of caregiver support services and counselling services (questionnaire). 2. Investigation of aspects of the individual quality of life as well as spiritual needs of informal caregivers (qualitative interviews). In addition, other important aspects such as sociodemographic data, migration background, reasons for care etc. and its relationship with use and non-use of support services and counseling services will be examined. |
| Ethics approval(s) |
1. Approved 08/08/2023, Ethis Committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) (Krankenhausstrasse 12, Erlangen, 91054, Germany; +49 (0)9131 85-22270; ethikkommission@fau.de), ref: 20-220_3-B 2. Approved 02/09/2022, Ethics Committee of the Technische Universität München (TUM) (Grillparzerstraße 16, München, 81675, Germany; +49 (0)89 4140-7737; ethikkommission@mri.tum.de), ref: 2022-416-S-NP |
| Health condition(s) or problem(s) studied | Needs and individual demands of informal caregivers |
| Intervention | Quantitative data (collected by questionnaires) and qualitative data (collected by qualitative interviews) are collected over different data collection points. In advance, a questionnaire was distributed for the first time by experts of the Medizinischer Dienst (MD) Bayern to informal caregivers in the German federal state of Bavaria in a separate research project ProCare (https://doi.org/10.1186/ISRCTN13390923). This provided the initial sample. The present longitudinal study builds on this initial sample and focuses on follow-up measurements, especially on reasons for the use/non-use of central support services and possible positive effects through the use of these. These two quantitative follow-up surveys by means of questionnaires will take place with approx. 1,500 persons 12 months after the distribution of the first questionnaire in the ProCare project and with approx. 1,000 persons 18 months after the distribution of the first questionnaire in the ProCare project. In addition, approx. 50 persons will be interviewed by qualitative interviews; approx. 35 of these will be interviewed again after 12 months. |
| Intervention type | Other |
| Primary outcome measure | 1. Reasons for using or not using support services and care counselling, measured using self-report questionnaires 12 months and 18 months after the distribution of the first questionnaire in the ProCare project (https://doi.org/10.1186/ISRCTN13390923). 2. Aspects of individual quality of life and spiritual needs of informal caregivers, measured using qualitative interviews at baseline and (for approx. 35 of the approx. 50 people to be interviewed) also 12 months later. |
| Secondary outcome measures | All measured 12 months and 18 months after the distribution of the first questionnaire in the ProCare project (https://doi.org/10.1186/ISRCTN13390923): 1. Subjective burden of caregivers measured using the Burden Scale for Family Caregivers - short form (BSFC-s) 2. Quality of life of caregivers measured using a visual analogue scale (VAS) taken from the CarerQol-questionnaire 3. Benefits of being a caregiver measured using the Benefits of Being a Caregiver scale (BBCS) 4. Coping strategies measured using the COPE 6, derived from the Brief COPE questionnaire 5. Evaluation of the current care situation measured using questions based on the stress appraisal model of Lazarus 6. Health complaints measured using the Gießener Beschwerdebogen (GBB-24) 7. Depressiveness measured using the 9-item depression module of the Patient Health Questionnaire (PHQ-9) 8. Physical activity of caregivers measured using questions based on the RKI Survey Gesundheit in Deutschland aktuell 9. Loneliness of caregivers measured using the Short Scale for Measuring Loneliness 10. Relationship quality measured via self-report 11. Physical and mental health of caregivers measured using questions based on the Short-Form-Health-Survey (SF-12) 12. (Sociodemographic) data of caregivers including migration status measured via self-report 13. Utilization of informal support measured via self-report 14. (Sociodemographic) data of care receivers measured via self-report 15. Activities of daily living, instrumental activities of daily living, and supervision, measured by self-report questions |
| Overall study start date | 01/08/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,500 (explanation: In the precursor study ProCare (https://doi.org/10.1186/ISRCTN13390923), questionnaires were distributed to 25,000 informal caregivers in Bavaria by 500 experts from the "Medizinischer Dienst (MD) Bayern" from September to December 2022. Based on the authors' experience in previous studies, it was expected that approximately 6,000 of the 25,000 persons will fill out the first questionnaire and that approximately 1,500 will give informed consent for further questionnaires. |
| Total final enrolment | 995 |
| Key inclusion criteria | The participants are adult informal caregivers in the German federal state of Bavaria (Freistaat Bayern) who submitted an initial application for a care degree or an application for an increase in the care degree for the person being cared for. During the precursor study ProCare (https://doi.org/10.1186/ISRCTN1339092), 25,000 persons were contacted by the care advisors of the Medizinischer Dienst Bayern (MD Bayern) in the course of an assessment interview from September to December 2022 and received the first questionnaire. Participants of the current study are all persons who filled out the first questionnaire and gave their consent for further questionnaires. |
| Key exclusion criteria | Does not meet the inclusion critera |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Germany
Study participating centres
Erlangen
91054
Germany
München
80539
Germany
Sponsor information
Government
Haidenauplatz 1
München
81667
Germany
| Phone | +49 (0)89 540233-0 |
|---|---|
| poststelle@stmgp.bayern.de | |
| Website | https://www.stmgp.bayern.de/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals and presentations at national/international conferences |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anna Pendergrass (anna.pendergrass@uk-erlangen.de; regarding quantitative data from questionnaires) and from Prof. Dr Eckhard Frick (eckhard.frick@tum.de; regarding qualitative data from qualitative interviews). Data will be available in the time interval from 12 months until 36 months after the publication of the article. The data will be provided for non-commercial research purposes only to researchers with a proposal that was peer-reviewed and approved by an independent review committee. The inquiring researchers have to present an analysis plan and state the research purpose for which the data are needed, e.g. meta-analysis. Data will be available without any additional investigator support. The data that can be provided refer solely to the data underlying the presented results of the manuscript. They will be completely anonymized, and linkage to the stored data with personal information will not be possible, thus case-specific additional information/clarification cannot be provided anymore. |
Editorial Notes
17/07/2024: The following changes were made to the study record:
1. The overall study end date was changed from 31/07/2024 to 31/12/2024.
2. The intention to publish date was changed from 31/07/2025 to 31/12/2025.
07/09/2023: Study's existence confirmed by the ethics committees of the universities of Erlangen-Nuremberg (FAU) and Munich (TUM).
