search
Back to results

Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline (TRvsCS)

Primary Purpose

Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Group intervention
Sponsored by
Paulo Costa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Decline

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Sites / Locations

  • The Health Sciences Research Unit: Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reminiscence Therapy (RT)

Cognitive Stimulation (CST)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2021
Last Updated
January 7, 2022
Sponsor
Paulo Costa
Collaborators
Junta de Freguesia de Santo António dos Olivais, Centro Sociocultural Polivalente de São Martinho, Centro Social e Paroquial de Carapinheira do Campo, Obra Social de Torre de Vilela, Centro Social Paroquial de Pedrulha, Associação Nacional de Apoio ao Idoso, Santa Casa de Misericórdia de Cantanhede, Doce Viver - Residencial Sénior, Bruscos
search

1. Study Identification

Unique Protocol Identification Number
NCT05187572
Brief Title
Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline
Acronym
TRvsCS
Official Title
Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline: a Quasi-experimental Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
June 6, 2017 (Actual)
Study Completion Date
June 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paulo Costa
Collaborators
Junta de Freguesia de Santo António dos Olivais, Centro Sociocultural Polivalente de São Martinho, Centro Social e Paroquial de Carapinheira do Campo, Obra Social de Torre de Vilela, Centro Social Paroquial de Pedrulha, Associação Nacional de Apoio ao Idoso, Santa Casa de Misericórdia de Cantanhede, Doce Viver - Residencial Sénior, Bruscos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Treatment allocation will be done per institution, after a centralized randomization process. Care providers and outcome assessors will be blinded to the allocation process.
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reminiscence Therapy (RT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Stimulation (CST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cognition (person with cognitive decline)
Description
Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
Time Frame
Pre-intervention (baseline)
Title
Change in depressive dymptomatology (person with cognitive decline)
Description
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.
Time Frame
Pre-intervention (baseline)
Title
Change in quality of life (person with cognitive decline)
Description
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.
Time Frame
Pre-intervention (baseline)
Title
Change in cognition (person with cognitive decline)
Description
Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level.
Time Frame
8 weeks post baseline
Title
Change in depressive dymptomatology (person with cognitive decline)
Description
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.
Time Frame
8 weeks post baseline
Title
Change in quality of life (person with cognitive decline)
Description
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.
Time Frame
Pre-intervention (baseline), 8 weeks post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Unstable clinical condition; Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Silva, PhD
Organizational Affiliation
Health Sciences Research Unit: Nursing, Nursing School of Coimbra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
João Apóstolo, PhD
Organizational Affiliation
Health Sciences Research Unit: Nursing, Nursing School of Coimbra
Official's Role
Study Director
Facility Information:
Facility Name
The Health Sciences Research Unit: Nursing
City
Coimbra
ZIP/Postal Code
3004-011
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Links:
URL
http://www.esenfc.pt/ecog
Description
Project website

Learn more about this trial

Effectiveness of Reminiscence Therapy Versus Cognitive Stimulation in Older Adults With Cognitive Decline

We'll reach out to this number within 24 hrs