Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context

May 9, 2018 updated by: Joao Apostolo, Escola Superior de Enfermagem de Coimbra
The project presented here respond to this emerging need by implementing a Reminiscence Therapy program dedicated to elderly people in an institutional context. This will be a multicenter, randomized controlled study in which the participants' allocation will be made without their knowledge. Before the randomization process, the screening evaluation will be done, which will allow to verify the presence of the inclusion and exclusion criteria. The target population will be people age 65 or above years who present cognitive decline. After the randomization process, participants will be allocated randomly in the experimental group where the reminiscence program (composed by a main strand and maintenance strand) or in the usual institutional care group. The evaluation of the participants will be carried out individually and will take place in four different moments.This study will be conducted in RSE in the central region of Portugal.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are an estimated 46 million people with major Neurocognitive Disorders, and this figure is expected to increase to double every 20 years, with about 131.5 million people diagnosed by 2050 (Prince et al., 2015). The economic impact is significant, with costs estimated at US $ 818 million (Prince et al., 2015). In 2018, this value is expected to reach the trillion US dollar level, with serious implications for global societies and government authorities (Prince et al., 2015). Elderly people with cognitive decline progressively lose their cognitive capacities and experience motor disorders, leading, in more advanced stages of the disease, to family and carer burden, which often culminate in their institutionalization.

According to Kuske et al. (2009), about 60% of all institutionalized people in industrialized countries present some form of dementia, which poses new challenges for these institutions and for its professionals. This process is inevitably associated with an increase in the prevalence of chronic degenerative diseases, particularly neurocognitive disorders (NCD). The category of NCD includes all the disorders in which the primary clinical deficit is in cognitive function, being this deficit acquired (documented by standardized neurological tests or by quantitative clinical evaluation), that is, it represents a decline from a previous functional level (APA, 2013).

In this sequential line, priority is given to the design of interventions that effectively focus on the stimulation of best practices for active aging, aiming at the implementation of measures that minimize the impact of NCD by slowing down their progression or modulating their associated symptomatology (Directorate General for Health, 2016). Knowing that the drugs introduced so far in clinical practice are restricted to symptomatic control, not being able to prevent the progression of the disease, non-pharmacological interventions have been gaining special prominence. The literature emphasizes the value of Reminiscence as a strategy for people with cognitive deficits. This stimulating intervention is based on the recovery of significant life events with special focus on resolving past conflicts.

Reminiscence is a pleasant and stimulating activity that contributes to the reduction of social isolation, revealing itself as a strategy to promote interpersonal relations (Cooney et al., 2014; Gibson, 2004). It has been reported as an intervention associated with pleasure, safety and sense of belonging (Cappeliez & O'Rourke, 2006). It is also a low-cost therapeutic option (Siverová & Bužgová, 2014). In addition, according to Westerhof, Bohlmeijer and Webster (2010), the exchange of autobiographical memories through Reminiscence, even in the final stages of the dementia, can produce considerable and measurable gains that are reflected in increased levels of well-being, decreased depression levels and improved cognitive function as well as increased verbal fluency.

In view of the above, it is considered that the implementation of a structured Reminiscence program can maximize cognitive functioning, improve depressive symptoms and promote quality of life by facilitating the adaptation process and contributing to the promotion of the dignity of people with cognitive decline and who are in Day Care regime or living in Residential Structures for the Elderly (RSE).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-232
        • Health Sciences Research Unit: Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have the capacity to informally consent participation in the study;
  • have the ability to remain in a group within 60 minutes;
  • have sufficient auditory capacity to participate in discussions;
  • have sufficient visual capacity to see the materials that are part of the applied program;
  • have criteria of cognitive decline.

Exclusion Criteria:

  • present an unstable clinical condition;
  • do not wish to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reminiscence Therapy
The Reminiscence program will consist of a set of sessions thematically sequenced topics that address the life course of the participant. Each session will integrate a group of activities that will be developed in group and will have a didactic character, privileging subjective interests and interpersonal communication.
Other: Reminiscence Therapy Program
The Reminiscence Therapy program is composed of: (i) main strand lasting 7 weeks, with sessions twice a week (total of 14 sessions); (ii) maintenance strand, which runs for 7 weeks, once a week (total of 7 sessions). The duration for each session will be 60 minutes.
NO_INTERVENTION: Control Group
The control group shall participate in the institutional care provided by the professionals of each RSE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the participant's Cognition
Time Frame: Intermediate assessment (week 7)
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Intermediate assessment (week 7)
Change from Baseline in the participant's Cognition
Time Frame: Post-intervention assessment (week 14)
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Post-intervention assessment (week 14)
Change from Baseline in the participant's Cognition
Time Frame: Five-week follow-up assessment (week 19)
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Five-week follow-up assessment (week 19)
Change from Baseline in the participant's Depressive Symptoms
Time Frame: Intermediate assessment (week 7)
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Intermediate assessment (week 7)
Change from Baseline in the participant's Depressive Symptoms
Time Frame: Post-intervention assessment (week 14)
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Post-intervention assessment (week 14)
Change from Baseline in the participant's Depressive Symptoms
Time Frame: Five-week follow-up assessment (week 19)
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Five-week follow-up assessment (week 19)
Change from Baseline in the participant's Quality of Life
Time Frame: Intermediate assessment (week 7)
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Intermediate assessment (week 7)
Change from Baseline in the participant's Quality of Life
Time Frame: Post-intervention assessment (week 14)
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Post-intervention assessment (week 14)
Change from Baseline in the participant's Quality of Life
Time Frame: Five-week follow-up assessment (week 19)
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Five-week follow-up assessment (week 19)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Enfermagem de Coimbra

Collaborators

The Health Sciences Research Unit: Nursing

Investigators

  • Principal Investigator: João LA Apóstolo, PhD, Nursing School of Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ANTICIPATED)

July 31, 2018

Study Completion (ANTICIPATED)

July 31, 2018

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (ACTUAL)

December 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECOG_REM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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