NCT05187572

Brief Summary

Although data suggest that non-pharmacologic therapies such as Reminiscence Therapy (RT) and Cognitive Stimulation (CS) can potentially maintain or reverse this trend, cognitive impairment can be a precursor to neurodegenerative processes. This study aimed to assess how an RT and a CS program affected cognition, depressive symptomatology, and quality of life (QoL) in older persons with cognitive decline who attended community support institutions in central Portugal. For seven weeks, a quasi-experimental study with two arms (RT and CS program) was conducted. The intervention was completed by 76 of the 109 older persons who were first screened (50 in the RT program, 26 in the CS program). In both groups, a pre- and post-intervention analysis revealed statistically significant differences in cognition, particularly in older adults' delayed recall ability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

December 21, 2021

Last Update Submit

January 7, 2022

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in cognition (person with cognitive decline)

    Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.

    Pre-intervention (baseline)

  • Change in depressive dymptomatology (person with cognitive decline)

    Measured using the 10-items Geriatric Depression Scale (GDS-10). Scale scores vary between 0 and 10 points; scores equal or above 2 points correspond to a screening diagnosis of depression.

    Pre-intervention (baseline)

  • Change in quality of life (person with cognitive decline)

    Measured using the World Health Organization Quality of Life - module for older adults (WHOQOL-OLD-8). Scale scores vary between 8 and 40 points; higher scores correspond to a higher level of quality of life.

    Pre-intervention (baseline)

  • Change in cognition (person with cognitive decline)

    Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.

    8 weeks post baseline

  • Change in depressive dymptomatology (person with cognitive decline)

    Measured using the 10-items Geriatric Depression Scale (GDS-10). Scale scores vary between 0 and 10 points; scores equal or above 2 points correspond to a screening diagnosis of depression.

    8 weeks post baseline

  • Change in quality of life (person with cognitive decline)

    Measured using the World Health Organization Quality of Life - module for older adults (WHOQOL-OLD-8). Scale scores vary between 8 and 40 points; higher scores correspond to a higher level of quality of life.

    Pre-intervention (baseline), 8 weeks post baseline

Study Arms (2)

Reminiscence Therapy (RT)

EXPERIMENTAL

The RT program is composed of activities that follow older adults' lifespan (e.g., school, professional life, travelling, holidays and celebrations, historical dates/moments). Such activities allow older adults to revive and share life-changing/significant moments and integrate them into their autobiographical narrative. The program was developed and validated by Gil and colleagues for Portuguese older adults with cognitive decline.

Behavioral: Group intervention

Cognitive Stimulation (CST)

EXPERIMENTAL

The CST intervention was based on the "Making a Difference" program, specifically developed for older adults with cognitive decline and previously adapted and validated to the European Portuguese language and culture. This program offers a sequence of activities that covers different cognitive domains and promotes older adults' socialization and self-esteem.

Behavioral: Group intervention

Interventions

This intervention was developed during 14 sessions, held twice a week, with a duration of 45 to 60 minutes each. The sessions were developed as group-based interventions, facilitated by a leader and a co-leader from each community institution.

Cognitive Stimulation (CST)Reminiscence Therapy (RT)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Ability to give informed consent before study commencement;
  • Ability to participate in group activities for a period between 45 to 60 minutes;
  • No pronounced impairment of their visual and auditory abilities;
  • Mild to moderate cognitive decline, assessed as a score equal to or below 20 points in the Six-Item Cognitive Impairment Test (6-CIT).

You may not qualify if:

  • Unstable clinical condition;
  • Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Health Sciences Research Unit: Nursing

Coimbra, 3004-011, Portugal

Location

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Rosa Silva, PhD

    Health Sciences Research Unit: Nursing, Nursing School of Coimbra

    STUDY CHAIR
  • João Apóstolo, PhD

    Health Sciences Research Unit: Nursing, Nursing School of Coimbra

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Treatment allocation will be done per institution, after a centralized randomization process. Care providers and outcome assessors will be blinded to the allocation process.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 12, 2022

Study Start

April 20, 2017

Primary Completion

June 6, 2017

Study Completion

June 6, 2017

Last Updated

January 12, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

The data presented in this study are available on request. The data are not publicly available due to ethical considerations, regarding personal information and respecting what was written in the signed informed consent.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The data presented in this study are available on request. The data are not publicly available due to ethical considerations, regarding personal information and respecting what was written in the signed informed consent.
Access Criteria
The data presented in this study are available on request. The data are not publicly available due to ethical considerations, regarding personal information and respecting what was written in the signed informed consent.

Locations