ClinicalTrials.gg
CompletedNCT05966207Updated Jul 28, 2023

Individual Intervention of Cognitive Stimulation

An interventional study of Individual Cognitive Stimulation in Cognitive Dysfunction, sponsored by Escola Superior de Enfermagem de Coimbra. Completed at 1 site in Portugal. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.

Sponsored by Escola Superior de Enfermagem de Coimbra · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Dec 2021, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Cognitive Dysfunction with a site in Portugal — 13 open to participants now, 14 under way, 1 of them phase 3. Cognitive Dysfunction · Portugal.

Enrollment
22nd of 33
53 · median 64
Started
2021
with 3 others
No phase
30 of 36
10 open now
Registered
20th of 36
by date
Lead sponsor
3 of 36
Escola Superior de Enfermagem de Coimbra

Among the 36 studies in Cognitive Dysfunction with a site in Portugal, this one is the 22nd largest by enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2021, is one of 30 with no phase, and was the 20th registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's enrollment of 53 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Open to participants now

13 of the 36 studies in Cognitive Dysfunction with a site in Portugal are open now.

All 13 open studies →

A study can be open while its sites in Portugal have not opened yet or have stopped. Only those recruiting at a site in Portugal →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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02

Study 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 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.

03

Conditions studied

  • Cognitive Dysfunction
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Individual Cognitive Stimulation

    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).

    Behavioral: Individual Cognitive Stimulation

Interventions

  • BehavioralIndividual Cognitive Stimulation

    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.

06

What researchers measure

Primary outcomes

  1. Cognition

    Assessed using the Saint Louis University Mental Status Test (SLUMS), by Tarik et al. (2006)

    Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)

  2. Quality of Life

    Assessed using the Quality of Life in Alzheimer's disease (QoL-AD) scale by Logsdon et al. (1999)

    Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)

Secondary outcomes

  1. Dementia-related behavioral symptoms

    Assessed using The Neuropsychiatric Inventory (NPI) by Cummings et al. (1994)

    Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)

  2. 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)

    Time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)

07

Study locations

1 site
  • The Health Sciences Research Unit: Nursing
    Coimbra, 3004-011, Portugal
08

References and documents

Individual participant data

Plan to share: Undecided — Individual participant data (IPD) will be made available upon reasonable request made to the principal investigator.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Jan 2023, 13 months.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 13 months is below that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2023
First posted
Jul 28, 2023
StartActual
Dec 27, 2021
Primary completionActual
Jan 30, 2023
CompletionActual
Jan 30, 2023
Last update
Jul 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05966207
Lead sponsor
Escola Superior de Enfermagem de Coimbra
Responsible party
Joao Apostolo (PhD, Escola Superior de Enfermagem de Coimbra) — Principal investigator
First posted
Jul 28, 2023
Start date
Dec 27, 2021
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023
Last update
Jul 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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