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

NCT04157673 | Completed Results

• 1 other identifier: FWA00008824
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Delay Discounting

  15 weeks

Study Arms (1)

Episodic Future Thinking introduced at 6 weeks

EXPERIMENTAL

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

Interventions

Episodic Future Thinking BEHAVIORAL

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.

Episodic Future Thinking introduced at 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Leonard H. Epstein, PhD
• Organization: University at Buffalo

lhenet@buffalo.edu

7168293400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will not be informed of the group that they are randomly assigned until the completion of the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor and Division Chief, Behavioral Medicine

Model Details: This study is a multiple-baseline single subject design; participants will be randomized to intervention at 6-week, 8-week, or 10-week.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: September 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Locations

US (1)