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

NCT06147479 | Completed

• 1 other identifier: REC/23/042
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Cognitive stimulation; Occupational therapy; randomised controlled trial; Activities of daily living; ADL

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the performance of activities of daily living (ADL) of participants

  ADL performance will be measured using the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. This scale was designed for the assessment of ADL outcomes for individuals with Alzheimer's disease in clinical trials. The scale consists of 23 items that includes 6 BADL and 17 IADL outcomes, scored on a range from 0 (patient does not perform the activity), to the highest score (patient is independent in the activity). The scale is administered with caregivers who are asked to rate the degree to which their care-recipient performs each item in the last four weeks. The ADCS-ADL has been identified to be a reliable and valid instrument, with high internal consistency and sensitivity to functional changes in individuals with mild-to-moderate dementia.

  This will be administered at baseline (week 0), and post-intervention (week 8).

Secondary Outcomes (5)

• Change from baseline in the global cognitive functioning of participants

  This will be administered at baseline (week 0), and post-intervention (week 8).

• Change from baseline in cognition of participants

  This will be administered at baseline (week 0), and post-intervention (week 8).

• Change from baseline in communication ability of participants

  This will be administered at baseline (week 0), and post-intervention (week 8).

• Change from baseline in quality of life of participants

  This will be administered at baseline (week 0), and post-intervention (week 8).

• Change from baseline in neuropsychiatric symptoms of participants

  This will be administered at baseline (week 0), and post-intervention (week 8).

Other Outcomes (1)

• Occupational performance within a group setting

  This will be rated by the group facilitators following each session (week 1,2,3,4,5,6,7).

Study Arms (2)

CS-ADL

EXPERIMENTAL

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.

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

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

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

CS-ADL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

University of Galway

Galway, Connacht, Ireland

Location

Related Publications (1)

• 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.

  PMID: 39226247 DERIVED

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Simone Ryan, BSc

  University of Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to group allocation where possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Occupational Therapist

Model Details: This will be a multi-center, parallel, single-blind, randomized trial of CS-ADL versus treatment as usual for people with mild-to-moderate dementia.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 27, 2023
• Study Start: November 3, 2023
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

IE (1)