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

• ClinicalTrials.gov Identifier: NCT02682472
• Recruitment Status: Unknown
• First Posted: February 15, 2016
• Last Update Posted: February 15, 2016
• Sponsor: University College, London
• Information provided by (Responsible Party): University College, London

Tracking Information

• First Submitted Date: January 22, 2016
• First Posted Date: February 15, 2016
• Last Update Posted Date: February 15, 2016
• Study Start Date: August 2015
• Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Dementia

Intervention

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

Experimental: SettleIN

SettleIN - Adjustment to care programme intervention

Intervention: Other: SettleIN - Adjustment to care programme

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 10, 2016): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2016
• Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02682472
• Other Study ID Numbers: 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

• 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: University College, London
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aimee Spector; UCL London

• PRS Account: University College, London
• Verification Date: January 2016