Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
Primary Purpose
Cognitive Decline, Dementia, Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Reminiscence Therapy Program
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Decline focused on measuring dementia, cognitive impairment, cognition, quality of life, depressive symptoms, Reminiscence Therapy
Eligibility 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.
Sites / Locations
- Health Sciences Research Unit: Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Reminiscence Therapy
Control Group
Arm Description
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.
The control group shall participate in the institutional care provided by the professionals of each RSE.
Outcomes
Primary Outcome Measures
Change from Baseline in the participant's Cognition
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Change from Baseline in the participant's Cognition
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Change from Baseline in the participant's Cognition
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Change from Baseline in the participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Change from Baseline in the participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Change from Baseline in the participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Change from Baseline in the participant's Quality of Life
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Change from Baseline in the participant's Quality of Life
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Change from Baseline in the participant's Quality of Life
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Secondary Outcome Measures
Full Information
NCT ID
NCT03370796
First Posted
November 30, 2017
Last Updated
May 9, 2018
Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
The Health Sciences Research Unit: Nursing
1. Study Identification
Unique Protocol Identification Number
NCT03370796
Brief Title
Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
Official Title
Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
July 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
The Health Sciences Research Unit: Nursing
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
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Dementia, Cognitive Impairment
Keywords
dementia, cognitive impairment, cognition, quality of life, depressive symptoms, Reminiscence Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reminiscence Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group shall participate in the institutional care provided by the professionals of each RSE.
Intervention Type
Other
Intervention Name(s)
Reminiscence Therapy Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in the participant's Cognition
Description
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Time Frame
Intermediate assessment (week 7)
Title
Change from Baseline in the participant's Cognition
Description
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Time Frame
Post-intervention assessment (week 14)
Title
Change from Baseline in the participant's Cognition
Description
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Time Frame
Five-week follow-up assessment (week 19)
Title
Change from Baseline in the participant's Depressive Symptoms
Description
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Time Frame
Intermediate assessment (week 7)
Title
Change from Baseline in the participant's Depressive Symptoms
Description
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Time Frame
Post-intervention assessment (week 14)
Title
Change from Baseline in the participant's Depressive Symptoms
Description
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Time Frame
Five-week follow-up assessment (week 19)
Title
Change from Baseline in the participant's Quality of Life
Description
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Time Frame
Intermediate assessment (week 7)
Title
Change from Baseline in the participant's Quality of Life
Description
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Time Frame
Post-intervention assessment (week 14)
Title
Change from Baseline in the participant's Quality of Life
Description
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Time Frame
Five-week follow-up assessment (week 19)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João LA Apóstolo, PhD
Organizational Affiliation
Nursing School of Coimbra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Research Unit: Nursing
City
Coimbra
ZIP/Postal Code
3000-232
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19193252
Citation
Kuske B, Luck T, Hanns S, Matschinger H, Angermeyer MC, Behrens J, Riedel-Heller SG. Training in dementia care: a cluster-randomized controlled trial of a training program for nursing home staff in Germany. Int Psychogeriatr. 2009 Apr;21(2):295-308. doi: 10.1017/S1041610208008387. Epub 2009 Feb 5.
Results Reference
background
Citation
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
Results Reference
background
Citation
APA (213). Diagnostic and statistical manual of mental disorders (5th ed).(American Psychiatric Association, Ed.). Arlington.
Results Reference
background
PubMed Identifier
25040857
Citation
Cooney A, Hunter A, Murphy K, Casey D, Devane D, Smyth S, Dempsey L, Murphy E, Jordan F, O'Shea E. 'Seeing me through my memories': a grounded theory study on using reminiscence with people with dementia living in long-term care. J Clin Nurs. 2014 Dec;23(23-24):3564-74. doi: 10.1111/jocn.12645. Epub 2014 Jul 12.
Results Reference
background
Citation
Gibson, F. (2004). The past in the present: Using reminisce in health and social care. Baltimore: Health Professions Press.
Results Reference
background
PubMed Identifier
16855036
Citation
Cappeliez P, O'Rourke N. Empirical validation of a model of reminiscence and health in later life. J Gerontol B Psychol Sci Soc Sci. 2006 Jul;61(4):P237-44. doi: 10.1093/geronb/61.4.p237.
Results Reference
background
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
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Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
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