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van CCT (UK)

van CCT (UK)

Inlife – Effectiveness of an online social support intervention to support caregivers of people with dementia

- candidate number25436
- NTR NumberNTR6131
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-okt-2016
- Secondary IDsERCPN- 172_20_03_2016_A1, Martin van Boxtel 
- Public TitleInlife – Effectiveness of an online social support intervention to support caregivers of people with dementia
- Scientific TitleProject InLife: effect evaluation of a virtual social platform for caregivers of people with dementia
- hypothesisThe null-hypothesis states that there is no difference between the intervention group and waiting-list control group on subjective well-being at the three follow-up time-points. The alternative hypothesis states that there is a difference within and between the two groups at the three follow-up time-points. We expect that the alternative hypothesis will be true demonstrating improved social support and feelings of competence.
- Healt Condition(s) or Problem(s) studiedDementia, Informal care-givers
- Inclusion criteria- Being a primary caregiver of a person that is diagnosed with dementia
- Person with dementia is living at home or in a nursing home
- Access to internet and a (tablet)computer
- Basic knowledge and skills about computers (as judged by the researcher)
- Willingness of the primary caregiver to invite at least two members of their social network to participate in Inlife
- Online informed consent is obtained
- Exclusion criteria- Caregiver not available more than 4 weeks during the study period
-Caregivers who are overburdened or have severe health problems (based on clinical judgment of knowledgeable practitioner, and based on his/her experience with the target group).
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate31-dec-2018
- Target number of participants122
- InterventionsThe primary objective of this study is to evaluate the effectiveness of Inlife: a newly developed online social support intervention for caregivers and people with dementia (PwD). Inlife aims to lower feelings of loneliness and the threshold to seek support, improve social support, feelings of competence and facilitate supply and demand of support within the personal social network of the primary caregiver and PwD. The website and online app are specifically designed for and with caregivers and PwD and includes several functionalities (e.g. overview of network members and care needs, timeline, personal messages, calendar, a personal carebook and dementia specific information resources). The Inlife website and app can be accessed at several online devices. Participants in the intervention group use inlife for a study period of 16-weeks and have the possibility to keep using Inlife afterwards. Participants in the waiting list control group get access to Inlife after the 16-week study period.
- Primary outcomePrimary effect measurements: feelings of competence and social support in the primary caregivers.
Primary process outcomes will be feasibility and usefulness of the Inlife intervention as assessed by costume made questionnaires and qualitative interviews in a subsample.
- Secondary outcomeSecondary outcomes will be feelings of loneliness, perceived stress, anxiety and depression, perseverance time and quality of life in the primary caregiver.
- TimepointsBaseline, 8-week, 16-week, 42-week (=6-month after 16-week study period) follow-up measurements during the intervention.
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+), ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale and objectives: Dementia is a major public health problem. Due to the rising number of PwD in our society many informal carers such as family members and friends will be involved in a stressful and burdensome caregiving process. Frequently, dementia caregivers experience feelings of social isolation, loneliness and a high threshold to seek support. Recently, an online social support intervention named Inlife was developed to support informal caregivers of PwD in daily life. In the present randomized controlled study the effect- and processes evaluation of the Inlife platform are conducted.
Study design and population: a randomized waiting list controlled trial with repeated measurement design is performed. 122 dyads –the primary caregiver and person with dementia- will use Inlife 16 weeks within their own social network. Prior to inclusion a screening will be conducted to assess inclusion and exclusion criteria. Online self-reported measurements will be completed by the primary caregiver, which will be send automatically by e-mail at baseline and 8-week, 16-week and 42 week follow-up.
Furthermore, log-data about user intensity and drop-out rates will be analysed.
Main study parameters/endpoints: we assess the effectiveness in terms of the abovementioned primary and secondary effect outcomes. Furthermore, a process evaluation of the feasibility and usability of the inlife intervention is performed, as assessed by an online questionnaire and qualitative interviews.
- Main changes (audit trail)
- RECORD20-okt-2016 - 2-feb-2018

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