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Alzheimer's Disease Reminiscence Quality of Life

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ClinicalTrials.gov Identifier: NCT01295957
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : February 15, 2011
Sponsor:
Information provided by:
Universidad Nacional de Rosario

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: reminiscence therapy Behavioral: comparison group Other: control Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. self rated quality of life [ Time Frame: 12 weeks ]
    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 :
  1. Social engagement scale [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   65 Years to 87 Years   (Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01295957


Locations
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Argentina
Faculty of Psychology
Rosario, Santa Fe, Argentina, 2000
Sponsors and Collaborators
Universidad Nacional de Rosario
Investigators
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Principal Investigator: daniel jl serrani azcurra, MD faculty of psychology
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: daniel serrani, faculty of psychology
ClinicalTrials.gov Identifier: NCT01295957    
Other Study ID Numbers: PSI851
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2010
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders