Caregiver Connect: An mHealth-based intervention for supporting immigrant family caregivers to persons with dementia at home
| ISRCTN | ISRCTN64235563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64235563 |
- Submission date
- 13/06/2023
- Registration date
- 27/06/2023
- Last edited
- 30/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The number of persons with dementia (PWD) is estimated to be 250,000 in Sweden and 14 million in India by the year 2050. In Sweden, PWD increasingly live in their own homes. Family caregiving can lead to stress, poor health and poor quality of life. In Sweden, in 2017, only 5% of the municipalities offered any kind of support to family caregivers (FCs) whose native language was other than Swedish. The main research question in this project is whether a mHealth-based intervention given by community workers improves the caregiving competence of non-European immigrant FCs of PWD living at home and is effective at reducing caregiver stress and depressive symptoms and improving quality of life. This study will include participants from municipalities in Sweden. They will be randomly put into an intervention group and a control group.
Who can participate?
Adult FCs of PWD living at home who are recipients of the intervention and social care professionals (SCPs) who will deliver the intervention
What does the study involve?
The intervention will be delivered through a mobile application (app) in 10 sessions covering specific subjects to enhance the caregiving competence of FCs, e.g., introduction to dementia, being a caregiver, mental strategies, mindset, activities, diet, sleep and where to find resources in the community.
The outcomes of the study are caregiving competence, caregiver stress, depressive symptoms and quality of life. The outcomes will be measured at baseline, after completion of the 10-week-long intervention in the intervention group and after another 10-week intervention in the control group. In-depth interviews will be performed with SCPs and FCs after the intervention to understand their experiences of the ease of use and practicality of the app and the relevance of the intervention. The usage of different features of the app will be measured.
What are the possible benefits and risks of participating?
The project aims to reduce stress, and depressive symptoms, and increase caregiver competence and quality of life of FCs taking care of persons with dementia at home by increasing the understanding of the illness and its related symptoms. It will also equip them with strategies on how to deal with the challenges of caregiving. The intervention is person-centered through direct interaction with the SCP. As the intervention is delivered by mobile application and can be used whenever the user chooses to, regardless of time and place, it offers flexibility.
It is possible that the intervention can affect the FCs negatively by improving their understanding of the disease and its progression, leading the caregiver to feel more stressed about their responsibilities. This risk can be lowered through guidance by the SCP who will be implementing the intervention.
Sometimes, when the FC tries to communicate with SCPs by text messages, it can trigger suspicion among the PWD cared for. This risk is lessened by the fact that the FC can choose a time of his/her convenience to communicate with the SCP so as not to affect the relationship within the family.
Where is the study run from?
Karolinska Institute (Sweden)
When is the study starting and how long it is expected to run for?
March 2023 to February 2026
Who is funding the study?
Swedish Research Council for Health, Working Life and Welfare (Sweden)
Who is the main contact?
Dr Zarina Nahar Kabir, zarina.kabir@ki.se (Sweden)
Contact information
Principal Investigator
Associate Professor of Public Health
Principal Researcher
Division of Nursing
Dept. of Neurobiology, Care Sciences and Society
Karolinska Institutet
Alfred Nobels Allé 23, 23300
Huddinge
141 52
Sweden
 ORCID ID |
0000-0003-0465-5701 |
|---|---|
| Phone | +46852483697 |
| zarina.kabir@ki.se |
Scientific
Associate Professor of Public Health
Principal Researcher
Division of Nursing
Dept. of Neurobiology, Care Sciences and Society
Karolinska Institutet
Alfred Nobels allé 23, 23300
Huddinge
141 52
Sweden
| Phone | +46 8 52483697 |
|---|---|
| zarina.kabir@ki.se |
Public
Associate Professor of Public Health
Principal Researcher
Division of Nursing
Dept. of Neurobiology, Care Sciences and Society
Karolinska Institutet
Alfred Nobels allé 23, 23300
Huddinge
141 52
Sweden
| Phone | +46 8 52483697 |
|---|---|
| zarina.kabir@ki.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Home, Internet/virtual |
| Study type | Prevention, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | m-Health based intervention by community workers to support family caregivers to persons with dementia living at home in Sweden |
| Study acronym | CARE-2-CONNECT-Sweden |
| Study objectives | A mHealth-based intervention given by community workers will improve the caregiving competence of non-European immigrant family caregivers of persons with dementia living at home which in turn will reduce caregiver stress and depressive symptoms, and improve quality of life. |
| Ethics approval(s) |
Approved 09/08/2023, Swedish Ethical Review Authority (Box 2110, Uppsala, 750 02, Sweden; +46104750800; registrator@etikprovning.se), ref: 2023-02911-01 |
| Health condition(s) or problem(s) studied | Strengthening caregiving competence thereby reducing stress, and depressive symptoms and improving the quality of life of non-European immigrant family caregivers of persons with dementia |
| Intervention | This randomized controlled study will include a waitlist control group. Participants from municipalities in Sweden with high immigrant density will randomly be assigned to the intervention group (n=44) and the waitlist control group (n=44). Participants in the study will include: 1. Family caregivers (FCs) of persons with dementia (PWD) living at home and are recipients of the intervention 2. Social care professionals (SCP) who will deliver the intervention The intervention will be delivered through a mobile application (app) in 10 sessions on specific subjects to enhance the caregiving competence of FCs, e.g., introduction to dementia, being a caregiver, mental strategies, mindset, activities, diet, sleep and where to find resources in the community. Outcomes will be measured quantitatively at baseline, after completion of a 10-week intervention in the intervention group and after another 10-week intervention in the control group. In-depth interviews will be performed with SCPs and FCs after the intervention to understand their experiences with the ease of use and practicality of the app. Analytics information logged on the backend system will be used to assess the usage of different features of the app. |
| Intervention type | Behavioural |
| Primary outcome measure | Caregiving competence measured using a questionnaire developed by the project team at baseline and 10 weeks after the intervention (in intervention and control groups) |
| Secondary outcome measures | 1. Caregiver stress, depressive symptoms and quality of life measured using the Zarit Burden Index-12, Patient Health Questionnaire-9 and Carer QoL, respectively at baseline and 10 weeks after the intervention in both intervention and control groups 2. Ease of use/practicality of the App measured using in-depth interviews directly after the intervention in the intervention group 3. Usage of different features measured using analytics information logged on the backend system at the end of the study |
| Overall study start date | 01/03/2023 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Carer, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 44 in intervention group and 44 in control group |
| Key inclusion criteria | 1. Adults who are of non-European immigrant background in Sweden 2. Have provided care to a person with dementia living at home for at least six months 3. Possess a smartphone or tablet 4. Have access to the Internet at his/her own cost 5. Able to read and write Swedish |
| Key exclusion criteria | 1. Family caregivers aged less than 18 years 2. Family caregivers suffering from conditions that impede communication |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Alfred Nobels Allé 23
Huddinge
14152
Sweden
Sponsor information
Government
Forte, Box 38084
Stockholm
10064
Sweden
| Phone | +46 (0)8-775 40 70 |
|---|---|
| forte@forte.se | |
| Website | http://www.forte.se/en/ |
"ROR" |
https://ror.org/02d290r06 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sets generated during and/or analysed during the current study are not expected to be made available due to ethical considerations. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/06/2024 | 17/06/2024 | Yes | No |
Editorial Notes
30/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2024 to 31/10/2025.
2. The overall study end date was changed from 28/02/2025 to 28/02/2026.
17/06/2024: Publication reference added.
03/01/2024: The recruitment start date was changed from 01/01/2024 to 01/03/2024.
03/10/2023: The ethics approval was added.
19/06/2023: Trials' existence confirmed by the Swedish Ethical Review Authority (Sweden).
