|- candidate number||23371|
|- NTR Number||NTR5521|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-nov-2015|
|- Secondary IDs||ZonMw 733050606|
|- Public Title||Meeting Centers3.0; Evaluation of the implementation and costeffectiveness of three new tailored interventions for people with dementia and their carers: DemenTalent, Dementelcoach and STAR-online training|
|- Scientific Title||Meeting Centers3.0; Evaluation of the implementation and costeffectiveness of three new tailored interventions for people with dementia and their carers: DemenTalent, Dementelcoach and STAR-online training|
|- hypothesis||It is expected that adding the three tailored interventions to the regular Meeting Centers Support programme will better enable attuning the support to the individual variation in needs and preferences of people with dementia and carers and will be more costeffective regarding self esteem, (neuro)psychiatric problems, experienced autonomy and quality of life of people with dementia and sense of competence and quality of life of their informal carers.|
|- Healt Condition(s) or Problem(s) studied||Dementia, Autonomy, Quality of life, Informal care-givers|
|- Inclusion criteria||Participants of Meeting centers for people with dementia and their carers which are at least two years operational.
People with dementia must have a diagnosis of dementia and are in the mild to moderate stages of dementia. Informal carers care for a person with dementia.|
|- Exclusion criteria||People without a diagnosis of dementia.
Informal carers not caring for a person with dementia|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2016|
|- planned closingdate||31-jan-2019|
|- Target number of participants||510|
|- Interventions||• DemenTalent: people with dementia are active as volunteers in the community based on their present talents. Of course well guided and supported. |
• Dementelcoach: carers of people with dementia receive telephone coaching (10x45 min in 20 weeks).
• STAR-online training: informal carers follow an internet-course on caring for a person with dementia and how to take care of themselves as a carer.
|- Primary outcome||- People with dementia:|
Zelfwaarderingsschaal (Rosenberg 1965), Neuropsychiatric Inventory (NPI, Cummings et al. 1994); for costeffectiveness EQ5D and ASCOT
- Informal carers: Short Sense of Competence scale (Vernooij-Dassen ea 1999)
|- Secondary outcome||- People with dementia Er-varen autonomie vragenlijst (Meiland & Dröes, 2006) en Dementia Quality of Life instrument (DQoL; Brod et al., 1999).|
- Informal carers: one question on Quality of life (fom TOPICS-MDS).
|- Timepoints||Baseline (before start of intervention) and after 6 months|
|- Trial web site||www.emgo.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. Rose-Marie Dröes |
|- CONTACT for SCIENTIFIC QUERIES||Dr. Rose-Marie Dröes |
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Stichting Dioraphte, Stichting Dijkverzwaring, Fonds Sluyterman Van Loo, Stichting RCOAK, Amsterdam, the Netherlands, Stichting Hofje Codde & Van Beresteyn, Bavo stichting|
|- Publications||not yet|
|- Brief summary||In this study the implementation and (cost)effectiveness of Meeting Centers 3.0 will be studied, in which three new interventions are added to the regular Meeting Centers Support programme for community dwelling people with mild to moderate dementia and their carers: DemenTalent for people with dementia, and Dementelcoach and STAR online training for informal carers. In a randomized controlled trial (randomization on center level) the (cost)effectiveness of Meeting centers 3.0 compared to regular Meeting centers will be studied in 32 Meeting centers in the Netherlands (16 experimental and 16 control centers). Outcome measures are self esteem, (neuro)psychiatric problems, experienced autonomy and quality of life of people with dementia, and sense of competence and quality of life of carers. This three year study starts in February 2016.|
|- Main changes (audit trail)|
|- RECORD||9-nov-2015 - 15-jan-2016|