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

August 5, 2021 updated by: University College, London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Multiple UK Care Home locations
        • Contact:
          • Janine Hayward

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SettleIN
SettleIN - Adjustment to care programme 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, post intervention (4-6 weeks after intervention start) and at one month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Aimee Spector, UCL London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/0201
  • 15/LO/0611 (Other Identifier: NRES Committee London - Camden & Kings Cross)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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