Clinical trial NCT06147479: Cognitive Stimulation in Daily Activities for People Living With Early to Middle Stage Dementia
Official title: Cognitive Stimulation in Activities of Daily Living for Individuals Living With Mild-to-Moderate Dementia (CS-ADL): a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Dementia, Mild
Dementia Moderate
Keywords: Cognitive stimulation
Occupational therapy
randomised controlled trial
Activities of daily living
ADL
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change from baseline in the performance of activities of daily living (ADL) of participants
timeFrame: This will be administered at baseline (week 0), and post-intervention (week 8).
Secondary outcomes:
measure: Change from baseline in the global cognitive functioning of participants
timeFrame: This will be administered at baseline (week 0), and post-intervention (week 8).
measure: Change from baseline in cognition of participants
timeFrame: This will be administered at baseline (week 0), and post-intervention (week 8).
measure: Change from baseline in communication ability of participants
timeFrame: This will be administered at baseline (week 0), and post-intervention (week 8).
measure: Change from baseline in quality of life of participants
timeFrame: This will be administered at baseline (week 0), and post-intervention (week 8).
measure: Change from baseline in neuropsychiatric symptoms of participants
timeFrame: This will be administered at baseline (week 0), and post-intervention (week 8).
Other outcomes:
measure: Occupational performance within a group setting
timeFrame: This will be rated by the group facilitators following each session (week 1,2,3,4,5,6,7).
Locations:
city: Galway
country: Ireland
facility: University of Galway
state: Connacht
Study officials:
affiliation: University of Galway
name: Simone Ryan, BSc
role: PRINCIPAL_INVESTIGATOR
References: