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Cognitive Rehabilitation for People With Mild-to-moderate Dementia

Primary Purpose

Dementia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring Cognitive Rehabilitation, Single Case Experimental Design, Self-efficacy, Goal setting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

The study will include three participant groups: People with Dementia (PwD), their nominated people and staff participants. PwD: Inclusion criteria Diagnosis of mild/moderate dementia. Currently on the caseload of OPCMHTs or the YOD service in NHSGGC. Undergone assessment by OPCMHTs or YOD service and deemed as eligible for CR Must have a carer that can act as their nominated person and is able to engage in the intervention and who will also need to provide informed consent. If the PwD are taking dementia-specific medication, they need to have been receiving a stable dose for at least one month, with no expectation of change during the trial. This study may include those who have a comorbid mental health disorder, brain injury, or other significant neurological disorder, where dementia is still considered by the patient's community mental health team to be the primary presenting difficulty. This is because we often see people who have dementia with comorbid health difficulties. They must be proficient in the English language, in order to complete outcome measures. Exclusion criteria A diagnosis of severe/advanced dementia. Those who do not have a carer than can act as their nominated person. Those who lack the capacity to consent. Nominated people: Inclusion criteria They must live with the PwD. They must be willing to take part in the intervention. They must be able to provide informed consent. They must be proficient in the English language. Exclusion criteria • They lack the capacity to consent Staff participants: Inclusion criteria They must be part of the clinical team. They must have health care degree which qualifies them for their post within the clinical team. They must be proficient in the English language. They must have access to clinical supervision (via a trainee or qualified clinical psychologist) to support their implementation of the NES resources. Exclusion criteria • They are not part of the clinical team.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Goal Attainment
    An adapted version of the Goal Attainment Scaling (GAS; Turner-Stokes, 2009) will be used to monitor intervention outcome. On a weekly basis goal achievement status will be recorded using the following GAS categories: (0) at baseline level/no change; (1) partially achieved - some progress from baseline but goal not achieved; (2) goal achieved; (3) more than expected change. In addition, (-1) will refer to deterioration from baseline.
    Memory Self-efficacy
    The Memory Loss Self-Efficacy Scale (Kurasz et al., 2021) was developed to assess persons with MCI's confidence in performing activities made challenging due to known cognitive deficits. The items on this scale assess self-efficacy for daily activities and managing disease in general, for example "How confident are you that you can do all the things necessary to manage your memory/cognitive difficulties on a regular basis?". Each item is scored on a 10-point scale, from 1 being "Not at all Confident" to 10 being "Totally Confident".

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2023
    Last Updated
    October 16, 2023
    Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06069882
    Brief Title
    Cognitive Rehabilitation for People With Mild-to-moderate Dementia
    Official Title
    Cognitive Rehabilitation for People With Mild-to-moderate Dementia: A Single Case Experimental Design Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 17, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cognitive Rehabilitation is an approach that teaches strategies to people with cognitive problems which helps them accomplish tasks which they find challenging. It is found to be helpful for People with Dementia (PwD) who typically are still able to learn new procedures for completing tasks they find difficult. NHS Education for Scotland (NES) have developed a workshop and staff resource that aims to provide health and social care staff in Scotland with the knowledge, skills, and resources to use CR with PwD in a consistent and evidence-based way. The resources developed by the NES are based on the CR in dementia evidence base. However, the usefulness of this programme for Scotland's health services has not been investigated. The aim of this study is to investigate whether staff assisted use of the CR resources leads to improved goal attainment and self-efficacy for PwD as well as explore the personal experiences of staff, PwD, and their carers of the NES Cognitive Rehabilitation in Dementia intervention, including the impact the intervention may have on participants' confidence in managing their condition. Six PwD who are seen by Older People's Community Mental Health Teams (OPCMHTs) or the Young Onset Dementia (YOD) service in NHS Greater Glasgow and Clyde (NHSGGC), six nominated persons who act as carers for the PwD, and six clinical team members providing the intervention will have an opportunity to be involved in the study. PwD will develop their own goal related to everyday activities. Their achievement with this goal will be measured many times before and after a CR intervention. The investigators will then investigate if there has been any change in goal success before and after they were given support from staff. The study will also aim to understand the experiences of people participating in CR by conducting interviews with them. The information gathered through the interviews will then be analysed to identify themes in relation to the research aims, such as confidence of PwD in managing their difficulties and facilitators/barriers to participating in the intervention. The investigators will explore appropriate academic journals with the academic supervisor and submit for publication. The participants will be given the option of receiving a summary sheet of the findings of the study. If successful, the investigators anticipate that the study could encourage greater use of CR interventions to support people with dementia. It is also hoped that insights will offer healthcare providers valuable information when creating services for people with dementia and their carers.
    Detailed Description
    The aim of this study is to investigate whether a Cognitive Rehabilitation (CR) intervention supported by NHS Education for Scotland Cognitive Rehabilitation in Dementia Resources enables people with dementia (PwD) to achieve personally relevant everyday goals, and increases confidence in the ability to manage cognitive difficulties (self-efficacy). Additionally we will explore the personal experiences of staff, PwD, and their carers of the NES Cognitive Rehabilitation in Dementia intervention, including the impact the intervention may have on participants' confidence in managing their condition. Cognitive Rehabilitation (CR) is an approach that teaches strategies to people with cognitive problems which helps them accomplish tasks which they find challenging. It is found to be helpful for People with Dementia (PwD) who typically are still able to learn new procedures for completing tasks they find difficult. NHS Education for Scotland (NES) have developed a workshop and staff resource that aims to provide health and social care staff in Scotland with the knowledge, skills, and resources to use CR with PwD in a consistent and evidence-based way. The resources developed by the NES are based on the CR in dementia evidence base. However, the usefulness of this programme for Scotland's health services has not been investigated. Six PwD who are seen by Older People's Community Mental Health Teams (OPCMHTs) or the Young Onset Dementia (YOD) service in NHS Greater Glasgow and Clyde (NHSGGC) will have an opportunity to be involved in the study. The study will use Single Case Experimental Design (SCED) methodology. Participants will develop their own goal related to everyday activities. Their achievement of this goal will be measured between 9-11 times and self-efficacy will be measured six times during the baseline and intervention phases of the study. The combined duration of the baseline and intervention phases is between 9 and 11 weeks. The investigators will then investigate if there has been any change in goal success and self-efficacy before and after they were given support from staff. The study will also aim to understand the experiences of people participating in cognitive rehabilitation for dementia by conducting interviews with them twice, prior to intervention and following the intervention. The information gathered through the interviews will then be analysed to identify themes in relation to the research aims, such as the confidence of people with dementia in managing their difficulties and facilitators/barriers to participating in the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Cognitive Rehabilitation, Single Case Experimental Design, Self-efficacy, Goal setting

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single Case Experimental Design
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Rehabilitation
    Intervention Description
    Cognitive Rehabilitation is a "person-centred, goal-oriented, problem-solving therapy aimed at managing or reducing functional disability, mitigating excess disability, and maximising engagement and social participation" (Clare et al., 2019, p. 710). For this multiple-baseline SCED, there will be a baseline phase where participants will be assessed on goal attainment without an intervention. This phase will be either 3, 4, 5 weeks long and be determined for the participants using an electronic randomiser programme. Thereafter, facilitators will help participants devise personal rehabilitation plans to achieve one of these goals using evidence-based rehabilitative methods. These methods may include the use of environmental adaptations and prompts, introduction of compensatory strategies, procedural learning of skills, and methods for learning or relearning relevant information. The personal rehabilitation plan is put into practice for 6 weeks during the intervention phase of the study.
    Primary Outcome Measure Information:
    Title
    Goal Attainment
    Description
    An adapted version of the Goal Attainment Scaling (GAS; Turner-Stokes, 2009) will be used to monitor intervention outcome. On a weekly basis goal achievement status will be recorded using the following GAS categories: (0) at baseline level/no change; (1) partially achieved - some progress from baseline but goal not achieved; (2) goal achieved; (3) more than expected change. In addition, (-1) will refer to deterioration from baseline.
    Time Frame
    9,10, or 11 weeks
    Title
    Memory Self-efficacy
    Description
    The Memory Loss Self-Efficacy Scale (Kurasz et al., 2021) was developed to assess persons with MCI's confidence in performing activities made challenging due to known cognitive deficits. The items on this scale assess self-efficacy for daily activities and managing disease in general, for example "How confident are you that you can do all the things necessary to manage your memory/cognitive difficulties on a regular basis?". Each item is scored on a 10-point scale, from 1 being "Not at all Confident" to 10 being "Totally Confident".
    Time Frame
    9, 10, or 11 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    The study will include three participant groups: People with Dementia (PwD), their nominated people and staff participants. PwD: Inclusion criteria Diagnosis of mild/moderate dementia. Currently on the caseload of OPCMHTs or the YOD service in NHSGGC. Undergone assessment by OPCMHTs or YOD service and deemed as eligible for CR Must have a carer that can act as their nominated person and is able to engage in the intervention and who will also need to provide informed consent. If the PwD are taking dementia-specific medication, they need to have been receiving a stable dose for at least one month, with no expectation of change during the trial. This study may include those who have a comorbid mental health disorder, brain injury, or other significant neurological disorder, where dementia is still considered by the patient's community mental health team to be the primary presenting difficulty. This is because we often see people who have dementia with comorbid health difficulties. They must be proficient in the English language, in order to complete outcome measures. Exclusion criteria A diagnosis of severe/advanced dementia. Those who do not have a carer than can act as their nominated person. Those who lack the capacity to consent. Nominated people: Inclusion criteria They must live with the PwD. They must be willing to take part in the intervention. They must be able to provide informed consent. They must be proficient in the English language. Exclusion criteria • They lack the capacity to consent Staff participants: Inclusion criteria They must be part of the clinical team. They must have health care degree which qualifies them for their post within the clinical team. They must be proficient in the English language. They must have access to clinical supervision (via a trainee or qualified clinical psychologist) to support their implementation of the NES resources. Exclusion criteria • They are not part of the clinical team.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andy Wheeler
    Phone
    07883355432
    Email
    andrew.wheeler16@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jon Evans
    Phone
    07890858057
    Email
    Jonathan.Evans@glasgow.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We will not be sharing IPD details to researchers beyond the research team

    Learn more about this trial

    Cognitive Rehabilitation for People With Mild-to-moderate Dementia

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