Evaluation of "Demenz anders sehen (Demas)", an Internet-based video conferencing support group for family caregivers of persons with dementia
| ISRCTN | ISRCTN09041430 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09041430 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/08/2013
- Registration date
- 10/09/2013
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Domestic care for a relative with dementia is often associated with symptoms of depression and high levels of stress. To assist family caregivers of people with dementia, we developed an internet-based video conferencing support group programme. It is called "Demenz anders sehen (Demas)" (A different perspective on dementia). The goal of our study is to find out how well this programme works. If found to be effective, this could be practised on a broader scale.
Who can participate?
Our study aims at family caregivers of persons with dementia in Germany.
What does the study involve?
The programme consists of ten weekly sessions of about 90 minutes. Each group (4-7 members plus facilitator) meets in the video-chatroom of Demas. Information on the disease itself, how to improve the well-being of the affected person, how to improve communication with the affected person and information on stress management is given throughout the ten sessions. Moreover, participants can exchange their experiences with each other and receive advice from the trained facilitator.
Participants are randomly assigned to two study groups: members of the intervention group can start into the program right away, while members of the waiting list group have to wait for three months before they can enter the programme.
What are the possible benefits and risks of participating?
The goal of the programme is to provide its participants with new knowledge on dementia care, to support them emotionally and thus help them cope with the caring situation more effectively. Possible benefits include a higher care-related efficiency, increased well-being and lower levels of stress and depression. Risks of participating mainly relate to the possible frustration of being allocated to the waiting list group. Frustration can also occur as a result of (perceived) technical problems in the chat-room.
Where is the study run from?
The study is fully internet based. It runs on the website www.demenz-anders-sehen.de, which is managed by the Berlin-based Delphi Ltd, Germany.
When is the study starting and how long is it expected to run for?
The study starts in August 2013 and is expected to run for 18 months.
Who is funding the study?
The study is funded by the National Association of Statutory Health Insurance Funds in Germany (GKV-Spitzenverband).
Who is the main contact?
Dr Peter Tossmann, tossmann@delphi-gesellschaft.de
Dipl.-Psych. Benjamin Jonas, jonas@delphi-gesellschaft.de
Contact information
Scientific
Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH
Kaiserdamm 8
Berlin
14057
Germany
| tossmann@delphi-gesellschaft.de |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Patient information can be downloaded from https://www.demenz-anders-sehen.de/studieninfos [German language] |
| Scientific title | Evaluation of "Demenz anders sehen (Demas)", an Internet-based video conferencing support group for family caregivers of persons with dementia - an online randomised controlled trial |
| Study acronym | Demas |
| Study objectives | Three months after randomisation and compared to a no-intervention wait list, participants of "Demas" will have a significantly lower subjective burden of caregiving and significant lower depression scores. Moreover, their caregiving related self efficacy will be significantly higher than in the wait list three months after randomisation. |
| Ethics approval(s) | Approved by the Ethics committee of the Magdeburg Stendal University of Applied Sciences on 29 July 2013 (ref: AZ 4973-34) |
| Health condition(s) or problem(s) studied | Family caregivers of persons with dementia |
| Intervention | After consenting to the study conditions, participants are asked to fill out the baseline questionnaire. Afterwards and provided the eligibility criteria are met participants who dont have a webcam or headset get this equipment free of charge by mail. To test the equipment, to introduce the participants to the video chat and to explain the next steps in the study, a staff member calls the participant and meets him/her in the video chat. After the equipment has successfully been tested in the video chat each participant is allowed for randomization. Randomization is done blockwise with sets of approx. 10 to 12 participants. There are two study groups: 1. Members of the intervention group can start into the program with the next scheduled intervention session. The intervention is group-based and consists of ten weekly sessions of about 90 minutes facilitated by Rehabilitation Psychologists (B.Sc.). Each group (4-7 members plus facilitator) meets in the video-chatroom of Demas. 2. Members of the wait list can commence using the program after three months. Follow-up surveys are conducted 3, 6 and 12 months after randomization. Just like the baseline measurement these surveys are conducted via online-questionnaire. |
| Intervention type | Other |
| Primary outcome measure | 1. Subjective burden of caregiving according to the "Berliner Inventar zur Angehörigenbelastung Demenz" (BIZA-D, Zank, Schacke & Leipold, 2006; [Berlin Inventory of Caregiver burden - Dementia]) 2. Satisfaction with one's own performance as a caregiver according to The Sense of Competence Questionnaire (SCQ German version, Pfeiffer et al, in preperation) The outcomes are measured at baseline and 3, 6 and 12 months after randomization. |
| Secondary outcome measures | 1. Depression according to PHQ-9 (German version; Löwe, Spitzer, Zipfel, & Herzog, 2002) 2. General Self Efficacy according to Allgemeine Selbstwirksamkeit Kurzskala (Beierlein et al., 2012) The outcomes are measured at baseline and 3, 6 and 12 months after randomization. |
| Overall study start date | 26/08/2013 |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 136 |
| Key inclusion criteria | 1. According to the family caregiver, the care recipient has been diagnosed with dementia. 2. The family caregiver provides care for at least 90 minutes per day. 3. There are no plans to admit the care recipient to a nursing home in the next six months. 4. The family caregiver himself / herself does not suffer from psychiatric disorders such as alcohol use disorder, schizophrenia, dissociative disorder, bipolar disorder, dementia. 5. The family caregiver has basic computer skills and has a computer with broadband internet connection. 6. The family caregiver ( male and female caregivers) is at least 18 years old. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 26/08/2013 |
| Date of final enrolment | 31/01/2015 |
Locations
Countries of recruitment
- Germany
Study participating centre
14057
Germany
Sponsor information
Not defined
Forschungsstelle Pflegeversicherung
Reinhardtstr. 30
Berlin
10117
Germany
| Website | http://www.gkv-spitzenverband.de/ |
|---|---|
"ROR" |
https://ror.org/03psr2094 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 2016 results in https://www.gkv-spitzenverband.de/media/dokumente/pflegeversicherung/forschung/projekte_unterseiten/demas/2016_11_29_Demas_Endbericht_Jun2016.pdf (added 29/05/2020) |
| IPD sharing plan |
Editorial Notes
29/05/2020: Publication reference added.
