SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1
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ClinicalTrials.gov Identifier: NCT02682472 |
Recruitment Status : Unknown
Verified January 2016 by University College, London.
Recruitment status was: Recruiting
First Posted : February 15, 2016
Last Update Posted : February 15, 2016
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Tracking Information | |||||
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First Submitted Date ICMJE | January 22, 2016 | ||||
First Posted Date ICMJE | February 15, 2016 | ||||
Last Update Posted Date | February 15, 2016 | ||||
Study Start Date ICMJE | August 2015 | ||||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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. [ Time Frame: Baseline, post intervention (4-6 weeks after intervention start) and at one month follow up ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1 | ||||
Official Title ICMJE | SettleIN - An Adjustment to Care Intervention for People With Dementia: A Feasibility Pilot Study in Care Homes | ||||
Brief Summary | 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Dementia | ||||
Intervention ICMJE | Other: SettleIN - Adjustment to care programme
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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Study Arms ICMJE | Experimental: SettleIN
SettleIN - Adjustment to care programme intervention
Intervention: Other: SettleIN - Adjustment to care programme
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 2016 | ||||
Estimated Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Resident sample:
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 |
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02682472 | ||||
Other Study ID Numbers ICMJE | 15/0201 15/LO/0611 ( Other Identifier: NRES Committee London - Camden & Kings Cross ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | University College, London | ||||
Study Sponsor ICMJE | University College, London | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University College, London | ||||
Verification Date | January 2016 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |