A Study of a Memory Intervention to Improve MA in PWMCI & FCG MA

NCT02761655 | Unknown

• 1 other identifier: NMRPD1E0811
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Dementia

Keywords

Dementia; Medication Adherence; Perspective Memory

Outcome Measures

Primary Outcomes (2)

• Medication adherence

  Medical adherence change among patients with cognitive impairment (PWCIs) received intervention in the sixth month after initial visit. The outcome will be measure using Electrical Monitoring System (EMS) and Family Caregivers Observation Diary in adherence rate.

  Baseline and sixth month after initial visit

• Dementia Quality of Life (DQoL)

  Quality of life change among PWCIs received intervention in the sixth month after initial visit. The outcome will be measured using DQoL questionnaire.

  Baseline and sixth month after initial visit

Secondary Outcomes (1)

• Family Caregivers Medication Administration Hassles (FCG-MAH)

  Baseline and sixth month after initial visit

Study Arms (2)

Control Group

NO INTERVENTION

Patients in both experimental and control groups will receive educations on cognitive impairment, dementia, community resources, and related medication as well as health promotion for PWCIs. The teaching material will be derived from the online resources such as Alzheimer Disease International and Taiwan Alzheimer's Disease Association (TADA) and reviewed by the expert panel as well. Written information will be given to both groups (patients and FCGs), which will be suitable to general public and address issues of cognitive impairment and FCG involvement.

Intervention Group

EXPERIMENTAL

Patients in both experimental and control groups will receive educations on cognitive impairment, dementia, community resources, and related medication as well as health promotion for PWCIs. The teaching material will be derived from the online resources such as Alzheimer Disease International and Taiwan Alzheimer's Disease Association (TADA) and reviewed by the expert panel as well. Written information will be given to both groups (patients and FCGs), which will be suitable to general public and address issues of cognitive impairment and FCG involvement. The intervention group will further receive memory strategies training on encoding and retention, retrieval, as well as execution and monitoring.

Behavioral: Memory Strategies

Interventions

Memory Strategies BEHAVIORAL

Memory strategies on encoding retention, retrieval, execution and monitoring

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Mandarin Chinese, Taiwanese, and Hakka dialect speakers
• Having a primary FCG who is familiar with patient's conditions and has taken care of the patient or supervised a hired caregiver to take care of the patient in the past three monthshaving a primary FCG who is familiar with patient's conditions and has taken care of the patient or supervised a hired caregiver to take care of the patient in the past three months
• MMSE scores between 27 to 24

You may not qualify if:

• Acute illnesses, severe depression (Chinese Geriatric Depression Scale, C-GDS \> 10)
• Impaired sensory symptoms (hearing loss and severe visual problems)
• Chronic alcohol abuse or use of drugs

Sponsors & Collaborators

• Chang Gung University: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Taoyuan Branch

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia; Medication Adherence

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yi-Chen Chiu, PhD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chen Chiu, PhD

CONTACT

+886-3-211-8800; yulandac@mail.cgu.edu.tw, lab.yulandac@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 4, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

TW (1)