Care of family caregivers of persons with dementia
| ISRCTN | ISRCTN46137262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46137262 |
| Secondary identifying numbers | Stav1 |
- Submission date
- 04/09/2019
- Registration date
- 10/10/2019
- Last edited
- 30/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Current plain English summary as of 15/07/2020:
Background and study aims
In Sweden, most people with dementia (PWD) live in their own home and are cared for by family members. The health consequences of caregiving of PWD include stress, depressive symptoms, loneliness and poor self-rated health. The aim of this study is to assess the effectiveness of introducing a mobile application through the existing health care system in Sweden for reducing stress, depressive symptoms and loneliness, and improving quality of life of family caregivers of PWD.
Who can participate?
Adult family members who have provided care to a person with dementia living at home for at least six months, possess a smartphone or tablet, have access to the internet at his/her own cost and are able to read and write Swedish.
What does the study involve?
The study is conducted in the Stockholm and Västerbotten Regions in a sample of 78 family caregivers of PWD. The intervention is implemented by dementia nurses randomly selected in each of the study sites. The family caregivers are selected from the network of the selected dementia nurses. The intervention is a mobile application (app) on a smartphone/tablet through which the family caregivers, in groups of 8-10, can communicate with peers and a nurse, exchanging ideas how to deal with the PWD’s behaviour and where family caregivers can get support in their neighborhood; discuss stressful events to get support from the nurse; conduct self-assessments of stress, depressive symptoms, loneliness, self-rated health, and quality of life; and nurses can make announcements to family caregivers. Data is collected through the app before and three time points after the 8-week long intervention to assess changes in the health outcomes of the family caregivers. In-depth interviews are done after the intervention to understand the experiences of family caregivers and dementia nurses regarding the ease of use and practicality of the app, especially in integrating in the existing healthcare system. Gender, socio-economic status, and lifestyle practices are taken into account in the collection and analysis of the data.
What are the possible benefits and risks of participating?
This intervention provides a platform for the rising digitally literate family caregivers of persons with dementia to alleviate stress and improve quality of life irrespective of distance to the nearest health center.
Where is the study run from?
The study will be conducted by two universities in Sweden, Karolinska Institute (lead centre) in Stockholm and Umeå University in Umeå
When is the study starting and how long is it expected to run for?
January 2019 to September 2025
Who is funding the study?
The study is financed by funding received from Kamprad Foundation and grants from Karolinska Institute.
Who is the main contact?
Dr Zarina Nahar Kabir
Zarina.kabir@ki.se
Previous plain English summary plan:
Background and study aims
In Sweden, most people with dementia (PWD) live in their own home and are cared for by family members. The health consequences of caregiving of PWD include stress, depressive symptoms, loneliness and poor self-rated health. The aim of this study is to assess the effectiveness of introducing a mobile application through the existing health care system in Sweden for reducing stress, depressive symptoms and loneliness, and improving quality of life of family caregivers of PWD.
Who can participate?
Adult family members who have provided care to a person with dementia living at home for at least six months, possess a smartphone or tablet, have access to the internet at his/her own cost and are able to read and write Swedish.
What does the study involve?
The study is conducted in the Stockholm and Östergötland Regions in a sample of 297 family caregivers of PWD. The intervention is implemented by dementia nurses randomly selected in each of the study sites. The family caregivers are selected from the network of the selected dementia nurses. The intervention is a mobile application (app) on a smartphone/tablet through which the family caregivers, in groups of 8-10, can communicate with peers and a nurse, exchanging ideas how to deal with the PWD’s behaviour and where family caregivers can get support in their neighborhood; discuss stressful events to get support from the nurse; conduct self-assessments of stress, depressive symptoms, loneliness, self-rated health, and quality of life; and nurses can make announcements to family caregivers. Data is collected through the app before and three time points after the 8-week long intervention to assess changes in the health outcomes of the family caregivers. In-depth interviews are done after the intervention to understand the experiences of family caregivers and dementia nurses regarding the ease of use and practicality of the app, especially in integrating in the existing healthcare system. Gender, socio-economic status, and lifestyle practices are taken into account in the collection and analysis of the data.
What are the possible benefits and risks of participating?
This intervention provides a platform for the rising digitally literate family caregivers of persons with dementia to alleviate stress and improve quality of life irrespective of distance to the nearest health center.
Where is the study run from?
The study will be conducted by two universities in Sweden, Karolinska Institute (lead centre) in Stockholm and Umeå University in Umeå
When is the study starting and how long is it expected to run for?
January 2019 to December 2021
Who is funding the study?
The study is financed by funding received from Kamprad Foundation and grants from Karolinska Institute.
Who is the main contact?
Dr Zarina Nahar Kabir
Zarina.kabir@ki.se
Contact information
Scientific
Dept. Neurobiology, Care Sciences and Society
Karolinska Institute
Alfred Nobels Allé 23
Huddinge
141 83
Sweden
 ORCID ID |
0000-0003-0465-5701 |
|---|---|
| Phone | +46 (0)709423439 |
| zarina.kabir@ki.se |
Study information
| Study design | Pragmatic intervention design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Care of Family Caregivers of Persons with Dementia (CAFCA): mobile application to alleviate stress and improve quality of life |
| Study acronym | CaFCa |
| Study objectives | The proposed project aims to assess the effectiveness of implementing a mobile application through existing health care system in Sweden in reducing stress and loneliness, and improving mental health and quality of life of family caregivers of persons with dementia. |
| Ethics approval(s) | Current ethics approval as of 25/05/2021: Approved 23/04/2019, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; Tel: + 46 (0)10 4750800; Email: registrator@etikprovning.se), Dnr: 2019-01632; Dnr: 2020-06882 Previous ethics approval: Approved 23/04/2019, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; Tel: + 46 (0)10 4750800; Email: registrator@etikprovning.se), Dnr: 2019-01632 |
| Health condition(s) or problem(s) studied | Stress, depressive symptoms, loneliness and quality of life of family caregivers of persons with dementia |
| Intervention | Using a pragmatic intervention design, this study will use pre- and post-intervention assessment to evaluate the effectiveness of the proposed intervention in a sample of 297 family caregivers (FC) of persons with dementia (PWD). The intervention will be implemented by approximately 30 healthcare professionals specialized in dementia care (HP) based in the municipalities in Sweden. The main thrust of the intervention is to provide professional support, with help of an interactive mobile app, to family members in their caregiving role for a PWD. Qualitative interviews with HPs and FCs form the groundwork of the development of the mobile app. By using the app on smartphone or tablet, the FC, in groups of 8-10, will communicate with peers and a HP exchanging ideas on how to deal with PWD’s behavioural and cognitive changes, and where FCs can get support; discuss stressful events; access mindfulness exercises focused on themselves. Quantitative data will be collected through the app before and at three timepoints after the 8-weeks long intervention to assess changes in the health outcomes of the FCs. In-depth interviews will be conducted after the intervention to capture the experiences of FCs and HPs regarding the ease of use and practicality of the app. |
| Intervention type | Mixed |
| Primary outcome measure | Caregiver stress is measured using Zarit Burden Interview questionnaire at baseline, directly after completion of the intervention, 4 weeks and 8 weeks after the intervention |
| Secondary outcome measures | 1. Depressive symptoms assessed using a 9 items Patient Health Questionnaire 2. Loneliness assessed with a single item question 3. Quality of life assessed with Carer QoL7D All assessments will be done at baseline, directly after completion of the intervention, 4 weeks and 8 weeks after the intervention |
| Overall study start date | 01/01/2019 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 78 |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. Adults who have provided care to a person with dementia living at home for at least six months 2. Possess a smartphone or tablet 3. Have access to the internet at his/her own cost 4. Able to read and write Swedish |
| Key exclusion criteria | Caregivers aged less than 18 years and/or with severe physical or mental illness restricting their ability as caregivers |
| Date of first enrolment | 15/09/2020 |
| Date of final enrolment | 23/11/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Karolinska Institute
Alfred Nobels Allé 23
Huddinge
141 83
Sweden
Umeå
90187
Sweden
Sponsor information
University/education
Division of Nursing
Dept of Neurobiology, Care Sciences and Society
Alfred Nobels Allé 23, Plan C4
Huddinge
141 83
Sweden
| Phone | +46 (0)852483697 |
|---|---|
| zarina.kabir@ki.se | |
| Website | https://ki.se/ |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
University/education
No information available
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The conventional publications in peer reviewed scientific journals will begin in the second year of the project after the first completed data collection phase. Publications are expected to continue after the formal completion of the project. Scientific outputs and learning from the research project will be used as pedagogic material in the education programmes in both undergraduate nursing programme and specialist nursing programme of Older People Nursing. Students of these nursing programmes will be encouraged to participate in the data collection and analysis for utilization in their project theses (Bachelor’s and ‘Magister’). Presentations in national and international conferences, seminars/webinars and workshops, and other professional and community forums will be made to reach the general audience. If potential lessons can be taken from the intervention on primary health care delivery, they will be disseminated to the relevant policy makers in the form of policy notes. Communication about the intervention project will also be done on social media and professional networks, e.g. Twitter, Facebook, ResearchGate, LinkedIn. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as the application for ethical approval of the study specified the researchers of the research team who would have access to the participant level data. The data will be stored at a secure server of the lead university, Karolinska Institute. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/08/2020 | 03/09/2020 | Yes | No |
| Other publications | Qualitative results | 25/06/2024 | 30/01/2025 | Yes | No |
Editorial Notes
0/01/2025: The following changes were made to the study record:
1. Publication reference added.
2. The recruitment end date was changed from 31/08/2022 to 23/11/2023.
3. The overall study end date was changed from 31/12/2023 to 30/09/2025.
4. Total final enrolment added.
12/12/2022: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2022 to 31/12/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 01/12/2022 to 01/12/2024.
03/06/2021: The intention to publish date has been changed from 01/12/2020 to 01/12/2022.
25/05/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2020 to 15/09/2020.
2. The recruitment end date has been changed from 31/05/2021 to 31/08/2022.
3. The overall trial end date has been changed from 31/12/2021 to 31/12/2022.
4. The ethics approval has been updated.
5. The plain English summary has been updated to reflect the changes above.
03/09/2020: Publication reference added.
15/07/2020: The following changes have been made:
1. The total target enrolment and the target number of participants have both been changed from 297 to 78.
2. The recruitment start date has been changed from 01/10/2020 to 01/09/2020.
3. The intention to publish date has been changed from 01/12/2019 to 01/12/2020.
4. The plain English summary has been updated.
04/09/2019: Trial's existence confirmed by ethics committee.
