DementiaCS-ADLNCT06147479
Cognitive Stimulation in Daily Activities for People Living With Early to Middle Stage Dementia
A study testing CS-ADL (Cognitive stimulation in Activities of Daily Living) in people with Dementia and Dementia, Mild, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Dementia, Mild, Dementia Moderate
- What is being tested?
- CS-ADL (Cognitive stimulation in Activities of Daily Living)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIreland
- Study dates
- 3 Nov 2023to 21 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Stimulation in Activities of Daily Living for Individuals Living With Mild-to-Moderate Dementia (CS-ADL): a Pilot Randomised Controlled Trial
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:
Read more
- 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
- Being tested
- CS-ADL (Cognitive stimulation in Activities of Daily Living)
- Keywords
- Cognitive stimulation, Occupational therapy, randomised controlled trial, Activities of daily living, ADL
- Medical subject headings
- Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-ADL (Cognitive stimulation in Activities of Daily Living)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcome will be measured using Montreal Cognitive Assessment (Blind). The MoCA-Blind is scored on a scale of 22 points as visual elements are excluded. Specificity remains on par with the original MoCA. Scores from the MoCA-Blind are converted to align with the scores of the original MoCA using the following equation (result multiplied by 30) divided by 22. The interpretation ranges of scores are as follows: a score of 18-25 points indicates mild cognitive impairment; 10-17 points indicates moderate cognitive impairment; and fewer than 10 points indicates severe cognitive impairment. Scores ranging from 26 to 30 are considered as normal.
Measured: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in cognition of participants
Cognition will be assessed using the Repeatable Battery for Assessment of Neuropsychological Status (RBANS). The RBANS is a commonly used brief battery of cognitive function for individuals with dementia. This battery consists of 12 subtests which assess five cognitive domains: immediate memory, visuospatial-constructional ability, language and delayed memory. This battery has demonstrated good reliability and adequate validity indicators. Scores on the RBANS can range from 40 to 160, with a lower score indicating more severe cognitive impairment.
Measured: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in communication ability of participants
Communication ability will be assessed using the Holden Communication Scale (HCS). This scale includes 12 items assessing the domains of conversation, awareness, humour, and responsiveness. Each items contains five response options ranging from 0 to 4. Total scores can range from 0 to 48 with higher scores indicating more communication difficulties. The HCS was initially developed to assess communication outcomes in reality orientation and reminiscence programs and has demonstrated good reliability and validity for use with PLwD. While there are limitations to reliability and validity data outside of the original development of the tool, the HCS has been used in various CS studies to assess communication.
Measured: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in quality of life of participants
QOL will be assessed using the Quality of Life-Alzheimer's Disease Scale (QOL-AD). This scale consists of 13 items spanning the domains of physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Response options include 1 (poor), 2 (fair), 3 (good) and 4 (excellent), with total scores ranging from 13-52. Higher scores indicate better quality of life. Assessment is delivered through an interview format and separate ratings are obtained from the participant themselves and the caregiver. Higher scores indicate a better quality of life. The QOL-AD has demonstrated good reliability and internal consistency and has been found to detect improvements in QOL in previous CS studies.
Measured: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in neuropsychiatric symptoms of participants
Mood will be assessed through the presence of neuropsychiatric symptoms as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q), a version of the Neuropsychiatric Inventory (NPI). The NPI-Q is a caregiver-based questionnaire that measures the presence and severity of 12 neuropsychiatric symptoms in PLwD, including delusions, hallucinations, apathy, disinhibition, and agitation/aggression. The severity scale runs from 1 to 3 points (1=mild, 2=moderate, 3=severe). The questionnaire also measures the respective level of caregiver distress associated with each symptom, with the scale running from 0 to 5 points (0=no distress, 5=extreme distress). The minimum score is 0 and the maximum score is 36, with higher scores indicating increased presence of neuropsychiatric symptoms. The scale is widely used in research, has demonstrated acceptable levels of internal consistency.
Measured: This will be administered at baseline (week 0), and post-intervention (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start3 Nov 2023
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ryan, National University of Ireland, Galway, Ireland
- Investigators
- Simone Ryan, BSc, Principal investigator, University of Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147479
- Sponsor's protocol ID
- REC/23/042
- Acronym
- CS-ADL
- Status last verified
- Aug 2024
- First submitted
- 15 Nov 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39226247
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Stimulation in Activities of Daily Living for Individuals Living With Mild-to-Moderate Dementia (CS-ADL): a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06147479
- Acronym / sponsor ID
- CS-ADL / REC/23/042
- Conditions
- Dementia, Dementia, Mild, Dementia Moderate
- Keywords
- Cognitive stimulation, Occupational therapy, randomised controlled trial, Activities of daily living, ADL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 27 Nov 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CS-ADL | Experimental | Behavioral: CS-ADL (Cognitive stimulation in Activities of Daily Living)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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | CS-ADL |
Primary outcome
Change from baseline in the performance of activities of daily living (ADL) of participants
Time frame: This will be administered at baseline (week 0), and post-intervention (week 8).
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.
5 secondary outcomes
Change from baseline in the global cognitive functioning of participants
Time frame: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in cognition of participants
Time frame: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in communication ability of participants
Time frame: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in quality of life of participants
Time frame: This will be administered at baseline (week 0), and post-intervention (week 8).
Change from baseline in neuropsychiatric symptoms of participants
Time frame: This will be administered at baseline (week 0), and post-intervention (week 8).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 39226247Ryan 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.
- Individual participant dataSharing planned: Undecided
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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.
Simone Ryan, BSc principal investigator
University of Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS-ADL (Cognitive stimulation in Activities of Daily Living) in people with Dementia and Dementia, Mild, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the performance of activities of daily living (ADL) of participants (time frame: This will be administered at baseline (week 0), and post-intervention (week 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147479, which also lists 1 linked publication.
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 6 Aug 2024.