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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01998711
Other study ID # 156/04
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated November 25, 2013
Start date October 2004
Est. completion date November 2007

Study information

Verified date September 2005
Source Bayside Health
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial Summary

Aims:

To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive impairment, assisted by family members or friends. To equip persons with mild cognitive impairment with specific skills to prevent memory failures and improve the capacity of patients and families to cope with everyday memory difficulties.


Description:

Participants:

The sample will consist of 60 families who have a family member reporting memory loss and who have recently been assessed within the Cognitive Dementia and Memory Service (CDAMS). Participants will include patients and a family member / close friend. The potential patient participants must have received a diagnosis of mild cognitive impairment following a comprehensive clinical assessment. They must also be English speakers, live in the community, have no evidence of significant visual or auditory impairment, and have no history of diagnosed alcohol or drug abuse or major psychological disorder. Potential family / friend participants are expected to be spouses or adult children.

Brief Description:

Patients and their carers will be assigned to either a 'brief intervention group' or a 'no intervention group'. Over 5 1 1/2 -hour weekly sessions, the brief intervention group will be taught a memory skills program which emphasises practical strategies for dealing with everyday memory problems. Interactive group discussion and 'take home' exercises are also included. The no intervention group will serve as a control group, and will receive only their usual care from the the memory clinic. At the completion of the study, the brief intervention will be offered to those in the no intervention group.

All participants will complete questionnaires about knowledge of memory techniques, common memory and behaviour problems and emotional health at pre-intervention, post-intervention and after a 3-month follow-up.

Methods of Data Analysis:

Outcome evaluation will be monitored by neuropsychological assessments of memory performance, and subjective self-reports. A 2 x 3 multivariate analysis of variance (MANOVA) will be used to assess differences on the experimental measures between groups (brief intervention, no intervention) across repeated assessment phases (pre-intervention, post-intervention, 3-month follow-up).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Participant presents with memory complaint Objective memory impairment on neuropsychological tests Normal general cognitive function Adequate activities of daily living Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines Living in the community Absence of significant visual or auditory impairment English speaker -

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)


Intervention

Behavioral:
Memory group
Five 1-1.5 hour weekly session of memory training

Locations

Country Name City State
Australia Caulfield General Medical Centre Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuropsychological measures of memory and attention
Primary Self-report on memory performance in everyday activities
Primary Self-report on use of memory strategies
Primary Informant report on memory performance in everyday activities
Primary Informant report on use of strategies
Primary Assessment of psychological wellbeing
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