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

Sponsor

Escola Superior de Enfermagem de Coimbra (Other)

Overall Status

Unknown status

CT.gov ID

NCT03370796

Collaborator

The Health Sciences Research Unit: Nursing (Other)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline Dementia Cognitive Impairment	Other: Reminiscence Therapy Program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Jul 31, 2018

Anticipated Study Completion Date :

Jul 31, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.