SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1
Primary Purpose
Dementia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SettleIN - Adjustment to care programme
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
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
Sites / Locations
- Multiple UK Care Home locationsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SettleIN
Arm Description
SettleIN - Adjustment to care programme intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02682472
First Posted
January 22, 2016
Last Updated
August 5, 2021
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT02682472
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SettleIN
Arm Type
Experimental
Arm Description
SettleIN - Adjustment to care programme intervention
Intervention Type
Other
Intervention Name(s)
SettleIN - Adjustment to care programme
Intervention Description
A programme for care home staff to support new residents with dementia quickly and successfully adjust to life in a care home
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janine Hayward
Email
janine.hayward.13@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee Spector
Email
a.spector@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Spector
Organizational Affiliation
UCL London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple UK Care Home locations
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine Hayward
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
SettleIN - Adjustment to Care in Dementia: An Intervention Feasibility Study v0.1
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