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Alzheimer's Disease Reminiscence Quality of Life

This study has been completed.
Sponsor:
Information provided by:
Universidad Nacional de Rosario
ClinicalTrials.gov Identifier:
NCT01295957
First received: February 14, 2011
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

The effectiveness of reminiscence for dementia has been claimed as an effective tool, but scientific validation and systematic assessment of this method is needed. Materials and Methods: A randomized controlled trial (RCT) was conducted to search whether a reminiscence program is associated with improvement of quality of life of demented long term care residents. The trial had three arms: interventional, comparison and control. The reminiscence program was modeled within a life-story approach, while comparison group received informal counseling to control for changes in quality of life resulting from social contacts. The Social Engagement Scale (SES) and Self-rated Quality of Life Index (SRQoL) were the outcome measures. The results were examined at baseline (T0), twelve weeks (T1), and 6 months (T2) after intervention. The sample had 135 subjects [intervention group (N=45), comparison group (N=45) and control group (N=45)].


Condition Intervention Phase
Alzheimer's Disease
 Behavioral: reminiscence therapy
Behavioral: comparison group
Other: control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of a Reminiscence Program to Improve Quality of Life of Alzheimer's Disease Long Term Care Residents Using a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Nacional de Rosario:

Primary Outcome Measures:
  • self rated quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    SRQoL measured using a multidimensional self-report instrument with 11 dimensions: comfort, functional competence, privacy, dignity, autonomy, meaningful activities, relationships, food enjoyment, spiritual well-being, security, and individuality. Each dimension is scored on a 4-point Likert scale, with 4 meaning often, 3 sometimes, 2 rarely and 1 never. Residents unable to use the 4-point scale could answer ''generally yes'' or ''generally no.'' These responses are scored as 3.8 and 1.5, respectively, based on a z score approximation method.


Secondary Outcome Measures:
  • Social engagement scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Social Engagement Scale rates resident status during the last seven days in areas such as ease interaction with others and doing planned or structured activities. Each item is ranked on a binary basis, as yes (1) or no (0) by the caregiver.


Enrollment: 135
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: reminiscence therapy, story telling
24 bi-weekly sessions of reminiscence therapy, lasting one hour each one, over a period of 12 weeks. Refers to the use of images, sentences or memorabilia which help to focus on specific segments of the life history of an individual, and stimulates the emergence of affect-laden personal recalls, which are later verbalized in the context of guided conversations. The term story life is intended to highlight samples of meaningful events of the subject's life rather than a historically structured biography. Three main variables contributed to successful reminiscing: individuality, evaluation and structure.
 Behavioral: reminiscence therapy
24 bi-weekly sessions of reminiscence therapy, lasting one hour each one, over a period of 12 weeks. The latter refers to the use of images, sentences or memorabilia which help to focus on specific segments of the life history of an individual, and stimulates the emergence of affect-laden personal recalls, which are later verbalized in the context of guided conversations12. The term story life is intended to highlight samples of meaningful events of the subject's life rather than a historically structured biography13. Three main variables contributed to reminiscing: individuality, evaluation and structure.
Other Name: reminiscence intervention
Placebo Comparator: comparison
control group was administered counseling and informal social contacts in bi-weekly sessions of one hour, but they didn't participate in reminiscence sessions to rule out the possibility that improvement in quality of life was due only to attention received and social stimulation.
 Behavioral: comparison group
The control group was administered counseling and informal social contacts in bi-weekly sessions of one hour, common subjects addressed by comparison group were social security incomes, diets, family visits.
Other Name: comparison
No Intervention: control
control group was administered counseling and informal social contacts in bi-weekly sessions of one hour,
 Other: control
advise and informal counseling
Other Name: control

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  Eligibility

Ages Eligible for Study:   65 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Alzheimer's disease
  • Able to communicate

Exclusion Criteria:

  • Active major psychiatric disorders
  • Acute or unstable chronic medical conditions
  • Blindness
  • Deafness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295957

Locations
Argentina
Faculty of Psychology
Rosario, Santa Fe, Argentina, 2000
Sponsors and Collaborators
Universidad Nacional de Rosario
Investigators
Principal Investigator: daniel jl serrani azcurra, MD faculty of psychology
  More Information

Additional Information:
investigational subjects about old age for students  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: daniel serrani, faculty of psychology
ClinicalTrials.gov Identifier: NCT01295957     History of Changes
Other Study ID Numbers: PSI851
Study First Received: February 14, 2011
Last Updated: February 14, 2011
Health Authority: Argentina: Human Research Bioethics Committee

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013