Mild Cognitive Impairment Clinical Trial
Official title:
Development and Evaluation of Support Groups for Patients With Mild Cognitive Impairment and Their Partners
This study aims at developing and evaluating a support group program for patients with mild
cognitive impairment (MCI) and their partners. These patients have defective memory function
but are not demented. However, there is an increased chance of developing dementia in the
near future; 10-15% per year for MCI patients, in contrast to 1-2% per year for healthy
elderly persons. For the patients and their caregivers this means that they are confronted
with feelings of uncertainty and fear towards the future. They also have many questions
about how to improve their memory problems and how to cope with other changes or
consequences.
The purpose of the support group program is to improve coping skills and facilitate
adaptation to the impairments, in order to reduce anxiety or depression and strengthen
feelings of competence in patients and their partners.
Status | Completed |
Enrollment | 110 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients with MCI (MCI criteria, Petersen, 2001 and Grundman, 2004) and their primary caregivers. Exclusion Criteria: - Mini-Mental State Examination (MMSE) < 23 - Severe mood disorder. - No motivation. - Severe language problems. - Premorbid relationship problems |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Ziekenhuis | Arnhem | Gelderland |
Netherlands | UMC Sint Radboud | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Netherlands Alzheimer Foundation |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | quality of life: RAND, GDS | pre and post treatment | No | |
Primary | caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP) | pre- and post intervention | No | |
Secondary | Illness cognitions: Illness Cognitions Questionnaire (ICQ) | pre and post treatment | No | |
Secondary | marital satisfaction: Maudsley Marital Questionnaire (MMQ) | pre and post treatment | No |
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