Plain English Summary
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 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
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Zarina Kabir
ORCID ID
http://orcid.org/0000-0003-0465-5701
Contact details
Dept. Neurobiology
Care Sciences and Society
Karolinska Institute
Alfred Nobels Allé 23
Huddinge
141 83
Sweden
+46 (0)709423439
zarina.kabir@ki.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Stav1
Study information
Scientific title
Care of Family Caregivers of Persons with Dementia (CAFCA): mobile application to alleviate stress and improve quality of life
Acronym
CaFCa
Study hypothesis
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
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
Study design
Pragmatic intervention design
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
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 trial start date
01/01/2019
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
78
Participant exclusion criteria
Caregivers aged less than 18 years and/or with severe physical or mental illness restricting their ability as caregivers
Recruitment start date
01/09/2020
Recruitment end date
31/05/2021
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institute
Dept. Neurobiology, Care Sciences and Society,
Karolinska Institute,
Alfred Nobels Allé 23
Huddinge
141 83
Sweden
Trial participating centre
Umeå University
Departement of Nursing
Umeå
90187
Sweden
Sponsor information
Organisation
Karolinska Institute
Sponsor details
Division of Nursing
Dept of Neurobiology
Care Sciences and Society
Alfred Nobels Allé 23
Plan C4
Huddinge
141 83
Sweden
+46 (0)852483697
zarina.kabir@ki.se
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Kamprad Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Karolinska Institutet
Alternative name(s)
Karolinska Institute, KI
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Funder name
Strategic Research Area Health Care Science: Karolinska Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
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.
Intention to publish date
01/12/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list