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

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02761655 on ClinicalTrials.gov