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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370796
Recruitment Status : Unknown
Verified May 2018 by Joao Apostolo, Escola Superior de Enfermagem de Coimbra.
Recruitment status was:  Active, not recruiting
First Posted : December 12, 2017
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
The Health Sciences Research Unit: Nursing
Information provided by (Responsible Party):
Joao Apostolo, Escola Superior de Enfermagem de Coimbra

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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

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.



Primary Outcome Measures :
  1. Change from Baseline in the participant's Cognition [ Time Frame: Intermediate assessment (week 7) ]
    Outcome Measure - Montreal Cognitive Assessment (MoCA)

  2. Change from Baseline in the participant's Cognition [ Time Frame: Post-intervention assessment (week 14) ]
    Outcome Measure - Montreal Cognitive Assessment (MoCA)

  3. Change from Baseline in the participant's Cognition [ Time Frame: Five-week follow-up assessment (week 19) ]
    Outcome Measure - Montreal Cognitive Assessment (MoCA)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370796


Locations
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Portugal
Health Sciences Research Unit: Nursing
Coimbra, Portugal, 3000-232
Sponsors and Collaborators
Escola Superior de Enfermagem de Coimbra
The Health Sciences Research Unit: Nursing
Investigators
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Principal Investigator: João LA Apóstolo, PhD Nursing School of Coimbra
Publications:
Directorate-General for Health. (2016). Portugal Saúde Mental em Números - 2015. Programa Nacional para a Saúde Mental. 75-86. Retrieved from http://www.apah.pt/media/publicacoes_tecnicas_sector_saude_2/Saude_Mental.pdf
APA (213). Diagnostic and statistical manual of mental disorders (5th ed).(American Psychiatric Association, Ed.). Arlington.
Gibson, F. (2004). The past in the present: Using reminisce in health and social care. Baltimore: Health Professions Press.
Siverová, J., & Bužgová, R. (2014). Influence Reminiscence Therapy on Quality of Life Patients in the Long-Term Hospital. Central European Journal of Nursing and Midwifery, 5 (1), 21-28
Westerhof, G. J., Bohlmeijer, E., & Webster, J. D. (2010). Reminiscence and mental health: A review of recent progress in theory, research and interventions. Ageing and Society, 30 (04), 697-721.
Prince, M., Wimo, A., Guerchet, M., Ali, G., Wu, Y., & Prina, M. (2015). World Alzheimer Report 2015 The Global Impact of Dementia. Alzheimer's Disease International. Retrieved from https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf

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Responsible Party: Joao Apostolo, Professor Coordenador, Escola Superior de Enfermagem de Coimbra
ClinicalTrials.gov Identifier: NCT03370796    
Other Study ID Numbers: ECOG_REM
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joao Apostolo, Escola Superior de Enfermagem de Coimbra:
dementia
cognitive impairment
cognition
quality of life
depressive symptoms
Reminiscence Therapy
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders