Condition category
Mental and Behavioural Disorders
Date applied
04/09/2019
Date assigned
10/10/2019
Last edited
10/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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

N = 297

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

01/10/2020

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

https://ki.se/

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

government non-federal

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

01/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/09/2019: Trial's existence confirmed by ethics committee.