Cognitive Stimulation in Daily Activities for People Living With Early to Middle Stage Dementia

NCT ID: NCT06147479

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2024-06-21

Brief Summary

The goal of this study is to test the effect of CS-ADL is on people living with early to middle stage dementia. The study also aims to evaluate the feasibility of conducting larger-scale research of CS-ADL.

The main questions it aims to answer are:

• What is the effect of CS-ADL on the ability of people with early to middle stage dementia to carry out their everyday activities?
• What is the effect of CS-ADL on the memory, mood, communication, and quality of life of people living with early to middle stage dementia? What is the feasibility of conducting large-scale research of CS-ADL?

Participants will take part in a group program that lasts 7 weeks, with one session per week, lasting two hours. Participants will take part in rewarding and stimulating activities, for example discussion, reminiscence, music, and practical activities such as baking, cooking, gardening. Participants will be asked to complete a variety of questionnaires before and after taking part in the group.

Researchers will compare a group receiving CS-ADL to a group receiving their usual care, to explore whether CS-ADL works well in comparison to typical treatment provided by the health services.

Conditions

Dementia; Dementia, Mild; Dementia Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

CS-ADL

CS-ADL is a multi-component cognitive stimulation program that aims to enhance performance of activities of daily living (ADL) for people living with mild-to-moderate dementia.

Group Type: EXPERIMENTAL

CS-ADL (Cognitive stimulation in Activities of Daily Living)

Intervention Type: BEHAVIORAL

CS-ADL sessions are delivered once weekly, for seven weeks. Sessions last approximately 2 hours. Sessions are themed around domains of everyday activities, for example 'Morning routine', ' Domestic Activities', 'Leisure'. Activities in each session follow this theme. A typical session begins with introductions, reality orientation, a group song and discussion of the news of the week. This is followed by a physical activity/game and ADL-focused cognitive stimulation activities. These activities include the identification and categorization of everyday items, discussion, reminiscence, planning and sequencing of ADLs and the completion of everyday writing/calculation tasks. This is followed by practice of an ADL. Examples of activities include making a breakfast, a simple gardening activity or sorting laundry. The session then ends with a summary and repeat of the group song, and a plan for the next session.

Treatment as Usual (TAU)

The control group continue to receive their usual care. This may differ between individuals, but may include physiotherapy, occupational therapy, nursing, medication or attendance at a day-care centre/day hospital. This treatment is decided by their healthcare provider who is external to the research team. It is possible that 'TAU' for some individuals dictates no treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CS-ADL (Cognitive stimulation in Activities of Daily Living)

CS-ADL sessions are delivered once weekly, for seven weeks. Sessions last approximately 2 hours. Sessions are themed around domains of everyday activities, for example 'Morning routine', ' Domestic Activities', 'Leisure'. Activities in each session follow this theme. A typical session begins with introductions, reality orientation, a group song and discussion of the news of the week. This is followed by a physical activity/game and ADL-focused cognitive stimulation activities. These activities include the identification and categorization of everyday items, discussion, reminiscence, planning and sequencing of ADLs and the completion of everyday writing/calculation tasks. This is followed by practice of an ADL. Examples of activities include making a breakfast, a simple gardening activity or sorting laundry. The session then ends with a summary and repeat of the group song, and a plan for the next session.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants must have a formal diagnosis of major neurocognitive disorder (dementia) as per the DSM-V criteria.
• Participants must have a mild-to-moderate cognitive impairment as classified by the Montreal Cognitive Assessment (MoCA).
• Participants must have some ability to communicate and understand communication, determined by a score of 1 or 0 on questions 12 and 13 of the Clifton Assessment Procedures for the Elderly-Behaviour Rating Scale.
• Participants must be able to see and hear well enough to participate in the group.

Exclusion Criteria

• Individuals with severe dementia, i.e., an MMSE<10, will be excluded as most CS interventions are not applicable for those with severe cognitive impairment.
• Participants will be excluded if they have significant uncontrolled disruptive behaviours.
• Premorbid diagnosis of a learning disability.
• A significant physical illness/disability that may affect participation during intervention sessions or assessments.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Simone Ryan

Principal Investigator; Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Ryan, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Galway

Locations

University of Galway

Galway, Connacht, Ireland

Countries

Ireland

References

Ryan SM, Brady O. Cognitive stimulation in activities of daily living for individuals with mild-to-moderate dementia (CS-ADL): Study protocol for a randomised controlled trial. PLoS One. 2024 Sep 3;19(9):e0309337. doi: 10.1371/journal.pone.0309337. eCollection 2024.

Reference Type: DERIVED

PMID: 39226247 (View on PubMed)

Other Identifiers

REC/23/042

Identifier Type: -

Identifier Source: org_study_id