Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes

Determine if an intervention consisting of future-thinking improves different facets of memory/executive function and/or decision-making.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: Episodic Future Thinking

Detailed Description

The aim of this study is to determine if a cognitive intervention is an efficacious method for improving medication adherence in adults with prediabetes or type 2 diabetes. Participants in this study will complete assessment sessions, as well as intervention sessions over a 15 week period. During this time, medication adherence will be monitored using a MEMS cap. The investigators hypothesize that, following the cognitive intervention, there will be improvements in participants' medication adherence, as well as in facets of memory.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Adults over the age of 18 with prediabetes or Type 2 Diabetes currently prescribed at least one oral medication for blood glucose regulation, or for related comorbidities e.g., hypertension, hyperlipidemia, and are relatively non-adherent to taking them (< 80% of prescribed doses taken), but are motivated and/or have the intent to better comply with their medication regimen, will be studied.

Prediabetes and Type 2 Diabetes: Participants must have a diagnosis of prediabetes or Type 2 Diabetes within the last 2 years or meet criteria for prediabetes or Type 2 Diabetes. The American Diabetes Association guidelines (Group, 2003) defines prediabetes and Type 2 Diabetes as Fasting Plasma Glucose (FPG) 100mg/dl or greater, 2h glucose 140mg/dl or greater after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) of approximately 5.4% or greater.

Exclusion Criteria:

Pregnancy: Women who are pregnant or lactating will be excluded from participation.

Substance use, abuse, or dependence: Individuals that currently have problems with substance dependence, addiction, or problematic substance use that would limit participation (e.g., binge drinkers, alcoholics, daily stimulant/opiate users) will be excluded.

Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; unmanaged psychiatric disorder (e.g., depression, anxiety, attention deficit hyperactivity disorder, schizophrenia), cognitive impairment that would impact memory (e.g., symptomatic concussion), or an intellectual impairment that would impact study adherence. Additionally, participants should be able to attend to all intervention sessions. If a participant is not able to make most sessions (e.g. participant is out of town during most of the study for work or vacation travel), they may be excluded from the study Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.

Use of medication adherence aids: individuals who currently use aids to assist with medication adherence (e.g., pill organizers, reminder apps)may be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Episodic Future Thinking introduced at 6 weeks; The intervention being researched is called episodic future thinking (EFT), which consists of imagining specific instances of one's future. In this study, participants will engage in EFT focused on imagining taking one's medication, guided by a research staff member in their intervention sessions in addition to weekly check-in calls across an 8-week period following a 6-week, 8-week or 10-week baseline period. The research staff member will conduct the intervention session using a semi-structured interview format in which they work to identify situations in which the participant encounters challenges with taking their medication and will ask questions to prompt the participant to imagine what successful medication adherence would consist of. Sessions may also involve imagining positive events resulting from successful medication adherence and the details surrounding those events.

Behavioral: Episodic Future Thinking; This intervention involves participants engaging in episodic future thinking in order to improve their medication adherence and overall prospective thinking ability. This intervention will be introduced following a 6-week, 8-week or 10-week baseline period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	The investigators will measure medication adherence using a medication event monitoring system (MEMS) that measured the frequency and time the medication bottle is opened. Percent adherence was calculated [(Quantity of pills dispensed - remaining)/(quantity prescribed per day*days since last refill)] *100. Percent change was calculated from the last week of baseline to the first week of EFT and the last week of EFT	15 weeks
Prospective Memory	Prospective memory ability will be assessed using an event-based version of the virtual week task. This is a computer-based task in which participants are asked to completed different events at specified times in the style of a board game. For the event-based task, participants were asked to complete an extra mouse click when certain words appeared on the screen. Possible scores ranged from 0 - 8 with higher scores being indicative of better prospective memory.	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay Discounting	Delay Discounting will be assessed using an adjusting amount task where choices will be present between a larger, delayed amount of money ($100) and a smaller, immediate amount. The smaller, immediate amount will begin at $50 on the first trial and will be adjusted following each trial. Participants cues created during treatment will be displayed during the task. To calculate discount rates area under the curve will be used, in which normalized values of delayed reward and normalized values of delay are used, resulting in values from 0.0 (all immediate choices) and 1.0 (all delayed choices) result. Units are proportion of maximum delayed reward x proportion of maximum delay.	15 weeks

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FWA00008824

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No