NCT06069882

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

September 29, 2023

Last Update Submit

October 16, 2023

Conditions

Keywords

Cognitive RehabilitationSingle Case Experimental DesignSelf-efficacyGoal setting

Outcome Measures

Primary Outcomes (2)

  • 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.

    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".

    9, 10, or 11 weeks

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • Staff participants:
  • 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.
  • They are not part of the clinical team.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single Case Experimental Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 6, 2023

Study Start

October 17, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

We will not be sharing IPD details to researchers beyond the research team