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Online Life Story Book: A study on its effect for people with early dementia and their caregivers


- candidate number24111
- NTR NumberNTR5939
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2016
- Secondary IDs70-73305-98-633 ZonMw dossier number
- Public TitleOnline Life Story Book: A study on its effect for people with early dementia and their caregivers
- Scientific TitleOnline Life Story Book: A study on its effect for people with early dementia and their caregivers
- ACRONYMOLSB
- hypothesisThe Online Life Story Book (OLSB) is an intervention that ties in with changes in care for persons with dementia. The hypothesis is that the intervention is more effective than usual care in preventing and diminishing neuropsychiatric symptoms in persons with early dementia.
- Healt Condition(s) or Problem(s) studiedDementia
- Inclusion criteriaMild cognitive impairment or early dementia; living at home and receiving informal care; being mentally competent to provide informed consent
- Exclusion criteriaPast psychotrauma
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate31-dec-2017
- Target number of participants106
- InterventionsE-health application. The Online Life Story Book is an e-health application that allows to place personal memories on a dynamic timeline. The timeline is easily marked with historical years. Memories like life events, anecdotes, photo’s, movies, voice fragments, music, recipes, preferences, and activities can be placed on the timeline. To make the application safe and warrant privacy, all information is stored on a secured server. The application is developed by Hellomydear in Belgium (www.hellomydear.be).
Materials. The application allows storage of materials that are directly relevant to the life story of the participant. Trained volunteers will support persons with dementia and their informal caregivers. Participants and their caregivers can make use of the online or printed version to recollect personal memories of the participant.
- Primary outcomeNeuropsychiatric symptoms (NPS) at follow-up (i.e., six months after the first measurement) are the primary outcome of the study. NPS are measured with the NeuroPsychiatric Inventory (NPI; Cummings et al., 1994).
- Secondary outcomeHealth related quality of life of the person with dementia is measured with the EQ5D (Brooks, 1996).
Care consumption of the person with dementia is measured in the TOPICS-MDS (Lutomski et al., 2015).
Caregiver Burden is measured with a Dutch questionnaire (Ervaren Druk door Informele Zorg or EDIZ; de Boer et al., 2012).
Caregiver burden is also measured with the distress scales of the NPI (Cummings et al., 1994; De Jonghe et al., 1997). The quality of life of the caregiver is measured with the CarerQol (Brouwer et al., 2006).
- TimepointsThere are three timepoints: one before the intervention (baseline), one after the intervention (three months after baseline), and one at follow-up (6 months after the baseline).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Teuntje Elfrink
- CONTACT for SCIENTIFIC QUERIES Teuntje Elfrink
- Sponsor/Initiator University of Twente, University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Alzheimer Nederland, PGGM
- Publications
- Brief summaryRationale: At present, about 260.000 people with dementia live in the Netherlands. This number will double over the coming twenty years. Dementia has a high burden for patients, informal caregivers and society. About two thirds of persons with dementia is estimated to live at home, but this number will increase given changes in long-term care. However, living at home with a good quality of life is not easy to achieve. Dementia is often accompanied by neuropsychiatric symptoms like apathy, agitation, hallucinations, depression, and anxiety. This is also related to the quality of life of the patient. Whereas the cognitive deterioration can hardly be influenced, it is possible to reduce neuropsychiatric symptoms. A good fit with the personal world of the person with dementia is an important condition for interventions. Reminiscence interventions can contribute as the recollection of valuable personal memories can give feelings of pleasure and trust. Memories are part of the autobiographical memory system that remains intact for a relatively long time in dementia. The Online Life Story Book (OLSB) is an intervention that nicely ties in with these changes in care for persons with dementia. The current study therefore wants to assess the effectiveness of this intervention for people with early dementia and their informal caregivers.
Objective: The primary objective of the study is to assess the effectiveness of the intervention “Online Life Story Book” on the primary outcome neuropsychiatric symptoms of persons with early dementia, in comparison to care as usual. The study has four secondary objectives: 1) to study the effectiveness of the intervention OLSB on the burden and quality of life of the primary informal caregiver; 2) to provide a first health economic evaluation by analysing the effects on the quality of life and care consumption of the person with early dementia; 3) to study the (time to) nursing home admittance as a longer term effect; 4) to evaluate the experiences of different stakeholders (patients, informal caregivers, volunteers, and professionals) as well as the use and complexity of the life story books.
Study design: A randomized controlled trial with individual randomization to one of two conditions is conducted: 1) the intervention condition: participants in the intervention “Online Life Story Book”; 2) the control condition: participants receive care as usual. Participants (persons with early dementia and their primary caregivers) fill out questionnaires at baseline, post-interventions (three months after baseline) and follow-up (six months after baseline).
Study population: In order to be eligible to participate in this study, a subject must meet the following criteria: 1) suffer from Mild Cognitive Impairment or early dementia; 2) living at home and receiving informal care; 3) being mentally competent to provide informed consent. Psychotrauma is an exclusion criterion.
Intervention: The Online Life Story Book is an e-health application that allows to place personal memories on a dynamic timeline. The timeline is easily marked with historical years. Memories like life events, anecdotes, photos, movies, voice fragments, music, recipes, preferences, and activities can be placed on the timeline. A trained volunteer assists the person with dementia and his or her informal caregiver in making the Online Life Story Book. The online version can be printed and both the online and printed version can be used to recollect personal memories.
Main study parameters/endpoints: The main study parameters are Neuropsychiatric symptoms (NPS) at follow-up (i.e., six months after the first measurement). NPS are measured with the NeuroPsychiatric Inventory (NPI). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The person with dementia and the informal caregiver fill out questionnaires at three moments in time (baseline, post-intervention, and follow-up) with a total time investment of 80 minutes for the person with dementia and 130 minutes for the informal caregiver. Participants are free to collaborate in the study. They may quit without reason and without consequences for the care they receive. The volunteer will visit the person with dementia and the informal caregiver five times for about one hour over the course of eight weeks. The informal caregiver will spend about one hour after each visit to collect materials that the volunteer will add to the Online Life Story Book. After the online life story book has been made the person with dementia and the informal caregiver are advised to spend one hour a week to recollect personal memories. Volunteers receive a training in which they gain insight into the personal world of dementia patients and their caregivers. They are also trained in communication skills and technical skills. They learn how to deal with negative memories and with privacy issues and to refer persons to their general practitioner when complaints worsen. There are no known negative effects of reminiscence. A possible side effect might be the recollection of negative memories. Therefore, persons with traumatic memories are excluded.
- Main changes (audit trail)
- RECORD14-mrt-2016 - 23-aug-2016


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