Alzheimer's Disease Reminiscence Quality of Life
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
1 other identifier
interventional
135
1 country
1
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 \[intervention group (N=45), comparison group (N=45) and control group (N=45)\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedFebruary 15, 2011
February 1, 2010
7 months
February 14, 2011
February 14, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
self rated quality of life
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.
12 weeks
Secondary Outcomes (1)
Social engagement scale
12 weeks
Study Arms (3)
reminiscence therapy, story telling
ACTIVE COMPARATOR24 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.
comparison
PLACEBO COMPARATORcontrol 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.
control
NO INTERVENTIONcontrol group was administered counseling and informal social contacts in bi-weekly sessions of one hour,
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Alzheimer's disease
- Able to communicate
You may not qualify if:
- Active major psychiatric disorders
- Acute or unstable chronic medical conditions
- Blindness
- Deafness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Psychology
Rosario, Santa Fe Province, 2000, Argentina
Related Publications (2)
Spector A, Thorgrimsen L, Woods B, Royan L, Davies S, Butterworth M, Orrell M. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Br J Psychiatry. 2003 Sep;183:248-54. doi: 10.1192/bjp.183.3.248.
PMID: 12948999BACKGROUNDSerrani Azcurra DJ. A reminiscence program intervention to improve the quality of life of long-term care residents with Alzheimer's disease: a randomized controlled trial. Braz J Psychiatry. 2012 Dec;34(4):422-33. doi: 10.1016/j.rbp.2012.05.008.
PMID: 23429813DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
daniel jl serrani azcurra, MD
faculty of psychology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
January 1, 2010
Primary Completion
August 1, 2010
Study Completion
November 1, 2010
Last Updated
February 15, 2011
Record last verified: 2010-02