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'Partner in Zicht' - an intervention to support caregivers of people with dementia in their daily lives


- candidate number19660
- NTR NumberNTR4847
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2014
- Secondary IDsNL50137.068.14 / METC 143040 
- Public Title'Partner in Zicht' - an intervention to support caregivers of people with dementia in their daily lives
- Scientific TitleDeal-iD Study: Dealing with daily challenges in Dementia - Effectiveness of an ESM-based intervention for spousal caregivers of people with dementia
- ACRONYMDeal-iD
- hypothesisThe null-hypothesis states that there is no difference before and after participating in the ESM-based intervention ‘Partner in Zicht’ and that there is no difference between the experimental group, the pseudo-experimental group and the control group in participant’s subjective well-being. The alternative hypothesis states that there is a difference within and between groups after participating in the ESM-based intervention. We expect the alternative hypothesis to be true, with increased feelings of competence and control in the caregiver and a decreased or constant level of depressive complaints after participation in the experimental group.
- Healt Condition(s) or Problem(s) studiedDementia, Informal care-givers
- Inclusion criteria- Being a spousal caregiver of a person that is diagnosed with dementia.
- Sharing a household with a demented person.
- Written informed consent is obtained.
- Exclusion criteria- Having insufficient cognitive abilities to engage in an ESM-based intervention (based on clinical judgment of knowledgeable practitioner, based on his/her experience with the target group).
- Having severe health problems (based on clinical judgment of knowledgeable practitioner, based on his/her experience with the target group).
- Being a caregiver of a person with dementia caused by Human Immunodeficiency Virus (HIV), acquired brain injury, Down syndrome, chorea of Huntington or alcohol abuse.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate31-dec-2015
- Target number of participants76
- InterventionsThe primary objective of this study is to evaluate the effectiveness of an ESM-based intervention, called ‘Partner in Zicht’. ESM will be implemented using the ‘PsyMate’, an electronic device that is specifically designed for momentary assessment in clinical practice. The PsyMate offers the possibility to give personally tailored feedback on relevant patterns of emotions, behaviors, and interactions with the person with dementia in daily life situations. Caregivers in the experimental group will participate in a 6-week intervention period in which they collect ESM data for three days a week. Every two weeks they will receive ESM-derived feedback in a face-to-face session with a coach. The feedback will give an overview of daily life activities, events and social situations and how these are related to momentary affective responses of the caregiver.
- Primary outcomePrimary outcomes will be feelings of competence, experienced control, and depressive complaints in the spouses.
- Secondary outcomeSecondary outcomes will be changes in ESM measurements of affect and emotional strength, and frequency and severity of behavioural problems in the patient and related emotional distress in the caregiver.
- TimepointsBaseline, post-intervention and 2 months follow-up.
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. M.E. Vugt, de
- CONTACT for SCIENTIFIC QUERIESDr. M.E. Vugt, de
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- Publications VAN KNIPPENBERG RJM, DE VUGT ME, PONDS RW, MYIN-GERMEYS I, VAN TWILLERT B, VERHEY FRJ. Dealing with daily challenges in dementia (deal-id study): an experience sampling study to assess caregiver functioning in the flow of daily life. Int J Geriatr Psychiatry 2016; DOI: 10.1002/gps.4552.
VAN KNIPPENBERG RJ, DE VUGT ME, PONDS RW, MYIN-GERMEYS I, VERHEY FR. Dealing with daily challenges in dementia (deal-id study): effectiveness of the experience sampling method intervention ’Partner in Sight’ for spousal caregivers of people with dementia: design of a randomized controlled trial. BMC Psychiatry 2016; DOI: 10.1186/s12888-016-0834-5.
VAN KNIPPENBERG RJM, DE VUGT ME, PONDS RW, MYIN-GERMEYS I, VERHEY FRJ. Dealing with daily challenges in dementia (Deal-id study): An experience sampling study to assess caregivers’ sense of competence and experienced positive affect in daily life. American Journal of Geriatric Psychiatry, accepted for publication.
- Brief summaryRationale and objectives: Dementia causes a major burden on both patients and caregivers. More than 80% of the caregivers are at risk of reaching their upper limits during the disease process. Ecologically valid information on how caregivers perceive and react on a daily basis to the challenges of dementia is lacking, making it difficult to gain insight into daily caregiver perceptions, moods, and activities in the presence and absence of the person with dementia. Therefore, we need to measure the subtle and finely-drawn patterns of interaction between patient and caregiver in the flow of daily life. The Experience Sampling Methodology (ESM) is specifically designed for such momentary assessment in daily life. The primary objective of this study is to evaluate the effectiveness of an ESM-based intervention, called ‘Partner in Zicht’ to increase spousal caregiver competence and feelings of control in managing daily challenges. Increased caregiver competence and control might prevent caregivers from depressive complaints and might lower the risk of becoming overburdened.
Secondary objectives are to evaluate the process and the costs of the intervention.
Study design and population: The study involves a randomized controlled trial in which 105 spousal caregivers of community dwelling patients with dementia will be randomly assigned to the experimental, pseudo-experimental, or control group. The experimental group receives a 3-day pre- and post-ESM assessment and continuous ESM assessment during the 6-week intervention period with feedback every two weeks. The pseudo-experimental group receives a 3-day pre- and post-ESM assessment and continuous ESM assessment during the 6-week intervention period without feedback. The control group receives a 3-day pre- and post-ESM assessment, but no additional intervention during the 6- week intervention period. Intervention: ESM will be implemented using the ‘PsyMate’, an electronic device that is specifically designed for momentary assessment in clinical practice. The PsyMate offers the possibility to give personally tailored feedback on relevant patterns of emotions, behaviors, and interactions with the person with dementia in daily life situations. Caregivers in the experimental group will participate in a 6-week intervention period in which they collect ESM data for three days a week. Every two weeks they will receive ESM-derived feedback in a face-to-face session with a coach. The feedback will give an overview of daily life activities, events and social situations and how these are related to momentary affective responses of the caregiver.
Main study parameters/endpoints: Primary outcomes will be feelings of competence, experienced control, and depressive complaints in the spouses. Secondary outcomes will be changes in ESM measurements of affect and emotional strength, and frequency and severity of behavioural problems in the patient and related emotional distress in the caregiver.
- Main changes (audit trail)11-dec-2016: Follow up: Amendement approved by METC: - 6 months follow up
- RECORD9-okt-2014 - 11-dec-2016


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