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SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University College, London

Tracking Information
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
 (submitted: February 10, 2016)
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.

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
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
Study Arms  ICMJE Experimental: SettleIN
SettleIN - Adjustment to care programme intervention
Intervention: Other: SettleIN - Adjustment to care programme
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
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:

  • 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:


• 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Anonymised and summarised data is planned for inclusion in an empirical paper to be submitted for publication. The summarised results will be fed back to participating care home managers and staff if desired.
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aimee Spector UCL London
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