- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02682472
SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1
SettleIN - An Adjustment to Care Intervention for People With Dementia: A Feasibility Pilot Study in Care Homes
Admission into a care home for people with dementia has been linked with both positive and negative psychological outcomes for both the resident and their carers. Whilst some people with dementia adjust quickly, many never adjust at all or adjustment is complex and linked to cognitive and behavioural decline (Wilson et al, 2007). Therefore, support for healthy adjustment is needed.
Recent research (Aminzadeh et al., 2013; Sury, Burns and Brodaty, 2013, Sussman and Dupuis, 2013) has identified factors that influence different relocation outcomes and prevent adverse reactions. There are currently no interventions that support successful adjustment by emphasising the positive factors found to influence relocation outcomes while mitigating the effects of negative influences and addressing any missed pre-admission procedures, reported in the literature.
The current project seeks to design an intervention that predominantly builds on the work of Sury et al (2013) and focuses on promoting healthy adjustment through an enhanced best practice based admission process.
The intervention will be developed through systematic review of the literature and consultation with professional experts, service users, care home staff and carers. The current study will serve as a feasibility (pilot) study and test the acceptability of the intervention design, examine recruitment and dropout and establish sample size for future, larger studies. It also aims to examine whether the intervention indicates an improvement in residents' quality of life, mood, overall adjustment and carer satisfaction with care.
All participants will receive a subset of the same intervention, specifically tailored to their needs and with elements delivered by staff, carer or psychologist. Staff and researchers will assess the improvement indicators mentioned above using relevant psychometric measures at baseline, post intervention completion and at one-month follow up. Indirect measures (interviews and staff field notes) will also be used to indicate intervention fidelity and feasibility.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Janine Hayward
- E-post: janine.hayward.13@ucl.ac.uk
Studera Kontakt Backup
- Namn: Aimee Spector
- E-post: a.spector@ucl.ac.uk
Studieorter
-
-
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London, Storbritannien
- Rekrytering
- Multiple UK Care Home locations
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Kontakt:
- Janine Hayward
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Site:
- Within Greater London
- At least one resident who has been recently admitted to care (ideally within the previous fortnight and no more than one month after admission).
- Sufficient cover to allow at least 1 staff lead to attend a half-day training
- Managerial assurance of adequate resources allowing staff participation
Resident sample:
- Meet diagnostic criteria for dementia according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V, APA, 2013)
- Score between FAST stage 2 and 6 representing a range of mild to moderately severe dementia on The Functional Assessment Staging Test (FAST, Reisberg, 1987)
- Be able to communicate in English
Staff sample:
• Working as a Nurse (registered nurses of any grade, student nurses) or Care Assistant (Health Care Assistants and nursing assistants).
DSM Criteria will be confirmed by formal diagnosis or use of the FAST as a screen.
Exclusion Criteria:
Site:
• Participation in any other research study
Resident sample:
• Score FAST stage 7 equating to severe dementia on The Functional Assessment Staging Test (FAST, Reisberg, 1987)
Staff sample:
• Lack of availability on training, intervention delivery and assessment dates
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: SettleIN
SettleIN - Adjustment to care programme intervention
|
A programme for care home staff to support new residents with dementia quickly and successfully adjust to life in a care home
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The primary outcome measure is change in residents' quality of life and measured by the Quality of Life in Alzheimer's Disease (QOL-AD, Lodgson et al, 1996) which will be administered by researchers.
Tidsram: Baseline, post intervention (4-6 weeks after intervention start) and at one month follow up
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Baseline, post intervention (4-6 weeks after intervention start) and at one month follow up
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Aimee Spector, UCL London
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15/0201
- 15/LO/0611 (Annan identifierare: NRES Committee London - Camden & Kings Cross)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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