A Study of a Memory Intervention to Improve MA in PWMCI & FCG MA
NCT02761655 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2016-05-10
Summary
Background and Purpose: Previous studies indicate that baseline cognitive abilities, especially prospective memory (PM) significantly influence medication adherence. However, there are only three qualified intervention studies on adherences in persons with cognitive impairment (PWCIs). In addition, family caregivers (FCGs) are often asked to assist PWCIs in managing their medication but FCGs' medication administration hassles are not intensively investigated. Therefore, the purpose of this project is to test the effectiveness and efficacy of a theoretical-based multifaceted memory intervention on medication administration and quality of life in PWCIs living at home and medication administration hassle of their FCGs.
Study Design: This is a three-year project (2015, 8, 1-2018, 7, 31). The aims of the first-year study are: 1.to develop a multifaceted memory intervention based on the paradigm of prospective memory (PM); 2. to pilot test the feasibility of the multifaceted memory intervention through a small randomized control trial. The aims of the second- to third year study are: 3. to examine the effectiveness and efficacy of the intervention (a randomized control trial). The intervention group will receive a cognitive impairment education, medication adherence and memory strategies training, while the control group will receive only the cognitive impairment education program. The duration of the intervention is one month. There will be 4 data collections (baseline, post-intervention 2 4, 6 months). Sample size estimation for the pilot study is 5 dyads for each group. Sample size for the randomized clinical trial is 84 dyads (42 dyads per group). After the attrition rate (10%) is counted, in total, there will be 200 cases (100 dyads). Implications of this project: This three-year program can help to identify those who may benefit from memory training and assist those who may be incompetent living in community. Also this program will extend the current knowledge of the role of PM playing in medication adherence behavior and its relationships with self awareness as well as everyday decision making among PWCIs. In addition, health related professionals can improve PWCI's quality of care and reduce FCG hassle by applying a theoretical guided practice for memory training.
Conditions
Interventions
- BEHAVIORAL
-
Memory Strategies
Memory strategies on encoding retention, retrieval, execution and monitoring
Sponsors & Collaborators
-
Ministry of Science and Technology, Taiwan
collaborator OTHER_GOV -
Chang Gung University
lead OTHER
Principal Investigators
-
Yi-Chen Chiu, PhD · Chang Gung University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-31
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
Countries
- Taiwan
Study Locations
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