Cognitive DysfunctionNCT05966207
Individual Intervention of Cognitive Stimulation
A study testing Individual Cognitive Stimulation in people with Cognitive Dysfunction, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
Trial summary
Population aging in Portugal has led to problematic social issues (American Psychiatric Association, 2013; Spector, Woods \& Orrell, 2008; Wimo \& Prince, 2010). At the same time, there is a noticeable increase in the prevalence of Neurocognitive Disorders (NCDs), commonly referred to in clinical practice as mild… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Individual Cognitive Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Dec 2021to 30 Jan 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults or near-elderly individuals (aged 60 years or above), diagnosed with mild cognitive impairment or dementia by a neurology or psychiatry specialist, or validated by a family physician based on DMS-III/IV/5 or ICD-9/10 criteria;
- Without significant physical illness or disability.
- Having an informal caregiver, whether a family member, friend, neighbor, or volunteer.
- Presence of mild to moderate cognitive impairment according to the 6-Item Cognitive Impairment Test (6CIT), translated and adapted by Apóstolo and Paiva (2015).
- Individuals with mild cognitive impairment or dementia who are capable of communication and understanding.
- Individuals residing in the community (at home).
- Having an available informal caregiver, whether a family member, friend, neighbor, or volunteer, who is capable of implementing the individual cognitive stimulation program.
Who cannot join
- Elderly individuals or informal caregivers with a history of serious psychiatric illness diagnosed before the age of 60 are excluded from participation.
- Informal caregivers with any level of cognitive impairment, even mild (according to DSM-5 criteria), are not eligible for inclusion.
- Elderly individuals residing in a social response facility, such as a nursing home or elderly residence, are not considered for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Making a Difference 3 - Individual Intervention of Cognitive Stimulation
Population aging in Portugal has led to problematic social issues (American Psychiatric Association, 2013; Spector, Woods \& Orrell, 2008; Wimo \& Prince, 2010). At the same time, there is a noticeable increase in the prevalence of Neurocognitive Disorders (NCDs), commonly referred to in clinical practice as mild cognitive impairment and dementia (Apóstolo, Cardoso, Silva \& Costa, 2014; Apóstolo \& Cardoso, 2014).
NCDs can be classified based on the degree of cognitive decline, ranging from mild to major, and based on etiology, which includes Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, and others (American Psychiatric Association, 2013).
Read more
In the European context, Portugal is among the minority of countries that do not have an official strategy for the care of people with mild cognitive impairment and dementia. Therefore, it is imperative to define national health policies that address the identified needs (Knapp et al., 2006).
Currently, non-pharmacological interventions, such as Individual Cognitive Stimulation (ICS), are gaining relevance as treatment responses to the aforementioned syndromes, due to the increasing clinical, social, and economic impact of mild cognitive impairment and dementia (Aguirre, Hoare, Spector, Woods, \& Orrell, 2014; Apóstolo et al., 2014).
ICS can be considered the implementation of a set of meaningful activities, carried out over several sessions, usually in a social context, with the aim of stimulating various domains, including attention, thinking, language, memory, and calculation (Aguirre et al., 2012; Apóstolo et al., 2014; Yates, Orrell, Spector \& Orgeta, 2015).
Current evidence supports the effectiveness of this intervention, indicating that ICS programs are associated with health benefits, particularly in cognition, mood, well-being, functional activity, quality of life, and communication skills (Apóstolo et al., 2014; Yates et al., 2014).
Providing care to people with mild cognitive impairment and dementia poses a challenge for the healthcare system, necessitating the implementation of specific interventions to increase self-care potential, autonomy, adaptation, and coping with deficits, as well as empowering the family and/or support network (Alzheimer Europe, 2013; Orrell et al., 2012; Woods, Aguirre, Spector \& Orrell, 2012; Yates et al., 2015). Due to the global pandemic context of SARS-CoV-2, social care institutions for the elderly underwent changes in their dynamics. One of the measures implemented during the emergency plan was the closure of adult day care centers. The elderly who previously attended these social care facilities are now staying in their own homes or with family/informal caregivers, thus being deprived of the social and cognitive stimuli they were accustomed to.
The mobilization of this population to their homes has led to increased social isolation and loneliness, which are underestimated public health risks. These factors affect a significant proportion of the elderly population and can lead to cognitive decline, feelings of loneliness, sadness, and abandonment, which were previously alleviated by the social care centers (National Academies of Sciences, Engineering, and Medicine, 2020).
Given the described situation, the Making a Difference 3 program - an ICS program - represents an excellent implementation option, as it can be developed in various contexts, including the home environment, using cost-effective resources, addressing many of the needs of both individuals with cognitive impairment and their informal family caregivers.
In summary, in Portugal, there is no established practice of implementing structured ICS interventions with individual sessions for use in the home environment. Thus, there is a need for the MD3 program to be disseminated to promote best practices. In response to the needs arising from the current pandemic context, the team of this project aims to produce national evidence on the effect of ICS in individuals with mild cognitive impairment and dementia, in the home environment of the elderly person, managed by informal caregivers and supervised by healthcare professionals.
- Conditions
- Cognitive Dysfunction
- Being tested
- Individual Cognitive Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Cognitive StimulationBehavioural
The Individual Cognitive Stimulation will be conducted by caregivers, with support by the research team. The intervention will span 12 weeks, consisting of three weekly sessions (30 minutes each session), totaling 36 sessions. Caregivers in this study will utilize a previously translated and validated version of "Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers," specifically adapted for the European Portuguese population.
| Study group | Role | What they receive |
|---|---|---|
| Individual Cognitive Stimulation | Experimental | The Individual Cognitive Stimulation (ICS) program to be implemented is called "Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers" (MD3). It was specifically designed to be applied in a home context, with informal/family caregivers taking charge of implementing the stimulation sessions (Apostolo, Silva, Costa \& Bobrowicz-Campos, 2019; Yates et al., 2015). The MD3 program has been translated and validated for the Portuguese culture and language (Silva, 2019). Receives: Behavioral: Individual Cognitive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Assessed using the Saint Louis University Mental Status Test (SLUMS), by Tarik et al. (2006)
Measured: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Quality of Life
Assessed using the Quality of Life in Alzheimer's disease (QoL-AD) scale by Logsdon et al. (1999)
Measured: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Secondary outcomes (2)
Dementia-related behavioral symptoms
Assessed using The Neuropsychiatric Inventory (NPI) by Cummings et al. (1994)
Measured: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Quality of the Carer-Patient Relantionship
Assessed using the Quality of the Carer-Patient Relationship (QCPR) scale by Spruytte et al. (2002), validated to the European Portuguese population by Silva et al. (2019)
Measured: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start27 Dec 2021
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joao Apostolo, Escola Superior de Enfermagem de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966207
- Sponsor's protocol ID
- FD3-2022
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be made available upon reasonable request made to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making a Difference 3 - Individual Intervention of Cognitive Stimulation
- ClinicalTrials.gov ID
- NCT05966207
- Acronym / sponsor ID
- FD3-2022
- Conditions
- Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 28 Jul 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.
Population aging in Portugal has led to problematic social issues (American Psychiatric Association, 2013; Spector, Woods \& Orrell, 2008; Wimo \& Prince, 2010). At the same time, there is a noticeable increase in the prevalence of Neurocognitive Disorders (NCDs), commonly referred to in clinical practice as mild cognitive impairment and dementia (Apóstolo, Cardoso, Silva \& Costa, 2014; Apóstolo \& Cardoso, 2014).
NCDs can be classified based on the degree of cognitive decline, ranging from mild to major, and based on etiology, which includes Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, and others (American Psychiatric Association, 2013).
In the European context, Portugal is among the minority of countries that do not have an official strategy for the care of people with mild cognitive impairment and dementia. Therefore, it is imperative to define national health policies that address the identified needs (Knapp et al., 2006).
Currently, non-pharmacological interventions, such as Individual Cognitive Stimulation (ICS), are gaining relevance as treatment responses to the aforementioned syndromes, due to the increasing clinical, social, and economic impact of mild cognitive impairment and dementia (Aguirre, Hoare, Spector, Woods, \& Orrell, 2014; Apóstolo et al., 2014).
ICS can be considered the implementation of a set of meaningful activities, carried out over several sessions, usually in a social context, with the aim of stimulating various domains, including attention, thinking, language, memory, and calculation (Aguirre et al., 2012; Apóstolo et al., 2014; Yates, Orrell, Spector \& Orgeta, 2015).
Current evidence supports the effectiveness of this intervention, indicating that ICS programs are associated with health benefits, particularly in cognition, mood, well-being, functional activity, quality of life, and communication skills (Apóstolo et al., 2014; Yates et al., 2014).
Providing care to people with mild cognitive impairment and dementia poses a challenge for the healthcare system, necessitating the implementation of specific interventions to increase self-care potential, autonomy, adaptation, and coping with deficits, as well as empowering the family and/or support network (Alzheimer Europe, 2013; Orrell et al., 2012; Woods, Aguirre, Spector \& Orrell, 2012; Yates et al., 2015). Due to the global pandemic context of SARS-CoV-2, social care institutions for the elderly underwent changes in their dynamics. One of the measures implemented during the emergency plan was the closure of adult day care centers. The elderly who previously attended these social care facilities are now staying in their own homes or with family/informal caregivers, thus being deprived of the social and cognitive stimuli they were accustomed to.
The mobilization of this population to their homes has led to increased social isolation and loneliness, which are underestimated public health risks. These factors affect a significant proportion of the elderly population and can lead to cognitive decline, feelings of loneliness, sadness, and abandonment, which were previously alleviated by the social care centers (National Academies of Sciences, Engineering, and Medicine, 2020).
Given the described situation, the Making a Difference 3 program - an ICS program - represents an excellent implementation option, as it can be developed in various contexts, including the home environment, using cost-effective resources, addressing many of the needs of both individuals with cognitive impairment and their informal family caregivers.
In summary, in Portugal, there is no established practice of implementing structured ICS interventions with individual sessions for use in the home environment. Thus, there is a need for the MD3 program to be disseminated to promote best practices. In response to the needs arising from the current pandemic context, the team of this project aims to produce national evidence on the effect of ICS in individuals with mild cognitive impairment and dementia, in the home environment of the elderly person, managed by informal caregivers and supervised by healthcare professionals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individual Cognitive Stimulation | Experimental | Behavioral: Individual Cognitive StimulationThe Individual Cognitive Stimulation (ICS) program to be implemented is called "Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers" (MD3). It was specifically designed to be applied in a home context, with informal/family caregivers taking charge of implementing the stimulation sessions (Apostolo, Silva, Costa \& Bobrowicz-Campos, 2019; Yates et al., 2015). The MD3 program has been translated and validated for the Portuguese culture and language (Silva, 2019). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older adults or near-elderly individuals (aged 60 years or above), diagnosed with mild cognitive impairment or dementia by a neurology or psychiatry specialist, or validated by a family physician based on DMS-III/IV/5 or ICD-9/10 criteria;
- Without significant physical illness or disability.
- Having an informal caregiver, whether a family member, friend, neighbor, or volunteer.
- Presence of mild to moderate cognitive impairment according to the 6-Item Cognitive Impairment Test (6CIT), translated and adapted by Apóstolo and Paiva (2015).
- Individuals with mild cognitive impairment or dementia who are capable of communication and understanding.
Key exclusion criteria (3 listed)
- Elderly individuals or informal caregivers with a history of serious psychiatric illness diagnosed before the age of 60 are excluded from participation.
- Informal caregivers with any level of cognitive impairment, even mild (according to DSM-5 criteria), are not eligible for inclusion.
- Elderly individuals residing in a social response facility, such as a nursing home or elderly residence, are not considered for this study.
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 |
|---|---|---|
| Individual Cognitive StimulationThe Individual Cognitive Stimulation will be conducted by caregivers, with support by the research team. The intervention will span 12 weeks, consisting of three weekly sessions (30 minutes each session), totaling 36 sessions. Caregivers in this study will utilize a previously translated and validated version of "Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers," specifically adapted for the European Portuguese population. | Behavioural | Individual Cognitive Stimulation |
Primary outcome
Cognition
Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Assessed using the Saint Louis University Mental Status Test (SLUMS), by Tarik et al. (2006)
Quality of Life
Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Assessed using the Quality of Life in Alzheimer's disease (QoL-AD) scale by Logsdon et al. (1999)
2 secondary outcomes
Dementia-related behavioral symptoms
Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
Quality of the Carer-Patient Relantionship
Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
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 28 Jul 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be made available upon reasonable request made to the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Cognitive Stimulation in people with Cognitive Dysfunction, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
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 7 inclusion and 3 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 28 Jul 2023. 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 Portugal. 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?
Cognition (time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.