A Study of a Memory Intervention to Improve Medicine Adherence in Patients With Mild Cognitive Impairments and Family Caregiver Medication Administration

These dyad participants are given more information and a follow up phone call to schedule a home visit for initial screening(24<MMSE<27). During the home visit, the participants will be given the consent forms and explanation of this project regarding the purpose, length of data collection and the types of measures of this study. Investigator will use the electronic monitoring system (EMS) developed by Professor Heh's lab, Chung Yuan Christian University in the Phase I to monitor the medication adherence behavior and pilot test its agreement with the pill count and the FCG observation diary. Investigator will apply for the compensations for participants for who finish the initial adherence observation (4 weeks) (baseline data collection). Those who are enrolled for the 6 month intervention phase will receive additional compensation if funded.

The research assistants are those who received training in the previous project (MOST 102-2314-B-182-050-MY2) but investigator will recruit a new part-time research assistant, a nursing master student, to receive a one-month training course, including: the purpose of this study, the procedures for recruitment, test battery interview skills, the test battery scoring system, data collection using the EMS, data download from the EMS, and basic statistical techniques. Then the newly trained part-time assistant will go to the participating sites for observing at least three PWCIs, practicing the interview skills with dyads, and familiarize herself with the outpatient clinical operational system. The on-site participant physicians in the memory disorder clinics will receive a written letter to explain the purpose of this project and the eligible criteria for the dyads. These physicians will help investigators to identify eligible dyads, while trained research assistants will implement the intervention and education program. The part-time student assistant is responsible for data collection.

The advantages of investigators team. The PI and most of the co-PIs come from the same research lab-Healthy Aging Research Center, Cognitive and Behavioral Indices Lab, Chang Gung University. This lab targets on populations such as normal older adults and those with dementia and disability. Investigator have developed own assessment tools and platform used to share the data such as the Prospective and Retrospective Memory Questionnaire (PRMQ). In the future, Investigator may share imaging technology. Therefore, investigators team has the advantages of integration of expertise. Interactions between experts will facilitate the progress of this project. Specifically, Dr. Hsu (a neurologist) will provide the clinical utility that ensures formal diagnosis and assessment for PWCIs. The external consultant (a psychologist), Professor Hua, will assist in administering psychometric tests, interpretation of data, and consultation on the content of intervention. Investigator have international collaboration partners such as Professor Jersey Liang from the University of Michigan, USA for longitudinal and experimental data analyses consultation and Dr. Heather Wilkinson from Edinburgh University, UK to focus on the dementia friendly community issues. Investigator hold monthly research meeting in the lab. Finally, the PI has research collaboration with Professor Heh, Chung Yuan Christian University, on the work of interactive mathematic training APP for MCI patients. Based on this foundation, Investigator will continue to develop the EMS in this project.

Phase 1 (1st year) procedures. After the dyads sign on the consented forms, Investigator spend about 3 hours to collect demographic data, test battery and teach the dyads how to move of patient's medication into the EMS box which contains a sensor to record when the container is opened. Investigator tell the dyads that the box can help patients count their medication pills and it must be used in each medication-taking event. Investigator also teach FCGs how to fill out a medication diary with their observation of patients' medication taking behavior. For those who have their own medication organizers, Investigator ask them to move one of their medications into the system for consistent measure. The baseline observation of medication adherence will last 4 weeks to screen out those who do not have adherence problems which are defined as adherence is less than or equal to 90% of the inter-dose interval over this 4-week medication monitoring period. The rationale for this inclusion criterion is that other studies found that using the EMS introduces some novelty that can initially boost adherence. Since the EMS is new to the participants who may experience this novelty, Investigator will adopt this stringent criterion comparing with the general definition of medication adherence >= 80% the inter-dose interval. At the end of 4 weeks, the trained part-time student assistant will down load the medication adherence data and remove the system from the dyad's house. If the PWCIs have multiple medications, Investigator will select only one (prioritizing order: dementia treatment, antipsychotic medicine, antihypertensive medicine). All the participant dyads will take turns to use the EMS system. During the first 6 months of the first year, Investigator will develop the teaching material and a protocol for phase I pilot study.

The intervention procedures in the pilot study consists of 5 stages: (1) initial home visit for baseline data collection; (2) measurement of baseline adherence over 4 weeks; (3) random assignment for eligible participants who sign on the informed consent forms to either intervention group or the educational comparison group; (4) four weekly in-home nurse visit to deliver the intervention or education control to the dyads; (5) adherence monitoring and outcome measures (over a 6 month period).