DementiaNCT06069882
Cognitive Rehabilitation for People With Mild-to-moderate Dementia
A study testing Cognitive Rehabilitation in people with Dementia, run by NHS Greater Glasgow and Clyde.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- They must be proficient in the English language, in order to complete outcome measures.
- 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.
- 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.
Who cannot join
- 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:
- Staff participants:
- They are not part of the clinical team.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cognitive Rehabilitation for People With Mild-to-moderate Dementia: A Single Case Experimental Design Study
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.
Read more
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Cognitive Rehabilitation
- Keywords
- Cognitive Rehabilitation, Single Case Experimental Design, Self-efficacy, Goal setting
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9,10, or 11 weeks
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".
Measured: 9, 10, or 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start17 Oct 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069882
- Sponsor's protocol ID
- UGN23NE239
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing IPD details to researchers beyond the research team
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation for People With Mild-to-moderate Dementia: A Single Case Experimental Design Study
- ClinicalTrials.gov ID
- NCT06069882
- Acronym / sponsor ID
- UGN23NE239
- Conditions
- Dementia
- Keywords
- Cognitive Rehabilitation, Single Case Experimental Design, Self-efficacy, Goal setting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 17 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Single Case Experimental Design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- They are not part of the clinical team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RehabilitationCognitive 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. | Behavioural | – |
Primary outcome
Goal Attainment
Time frame: 9,10, or 11 weeks
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
Time frame: 9, 10, or 11 weeks
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No. We will not be sharing IPD details to researchers beyond the research team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation in people with Dementia, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Wheeler (07883355432, andrew.wheeler16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment (time frame: 9,10, or 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.