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van CCT (UK)

van CCT (UK)

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

- candidate number23015
- NTR NumberNTR5526
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2015
- Secondary IDsECP-157 22 03 2015 Al 
- Public TitleInlife - an online social support intervention to support caregivers of people with dementia
- Scientific TitleInlife pilot study: An evaluation of the feasibility of an online social support intervention for caregivers of people with dementia
- hypothesisThe null-hypothesis predicts that Inlife is not feasible. The alternative hypothesis predicts that the Inlife intervention is evaluated as being feasible. We expect the alternative hypothesis to be true. Inlife will be feasible and minor revisions to the intervention and the study protocol will be needed to offer Inlife in an upcoming randomized controlled trial.
- 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
- Access to internet and a (tablet)computer
- Basic knowledge about computers (judged by researcher)
- Willingness of the primary caregiver to invite two members of their social network to participate in Inlife
- Written informed consent is obtained
- Exclusion criteria- Caregiver not available more than 4 weeks during the study period
- Expected placement in a care institution within the study period
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-okt-2015
- planned closingdate30-apr-2016
- Target number of participants20
- InterventionsThe primary objective of this study is to evaluate inlife: a newly developed online social support intervention for caregivers and people with dementia (PwD). Inlife aims to lower 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 is specifically designed for and with caregivers and PwD and includes several functionalities (e.g. overview of network members and care needs, timeline, notifications, dairy, dementia specific information resources). The Inlife website can be accessed at several online devices in the home setting.
- Primary outcomePrimary process outcomes will be feasibility and usefulness of the Inlife intervention and feasibility of measurements, log-data of intervention use
Primary effect measurements: feelings of competence, social support, and loneliness in the primary caregivers.
- Secondary outcomeSecondary outcomes will be changes in positive and negative emotions, anxiety and depression, quality of relationships, perceived stress and quality of life.
- TimepointsBaseline, 1-month, 2-month, 3-month and 4-month follow-up measurements during the intervention.
- Trial web
- statusplanned
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publications
- Brief summaryRationale and objectives: The majority of people with dementia (PwD) are living at home. As a consequence 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, Inlife an online social support intervention was developed to support informal caregivers of PwD in daily life. The present pilot study evaluates the feasibility and usability of the Inlife intervention. Furthermore, we assess the feasibility of the intervention protocol and online measurements in preparation of an upcoming randomized controlled trial.
Study design and population: a pilot study with a 'pretest-repeated measures, single group design'. 20 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, which will be send automatically by e-mail at baseline and monthly during the use of the Inlife application.
Furthermore, log-data about user intensity and drop-out rates will be analyzed.
Main study parameters/endpoints: Evaluation of the feasibility and usability of the inlife intervention as assessed by an online questionnaire designed by the researchers. Furthermore, we assess the feasibility of the online measurements of the abovementioned primary and secondary effect outcomes.
- Main changes (audit trail)
- RECORD21-okt-2015 - 19-jan-2016

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