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

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ClinicalTrials.gov Identifier: NCT04157673
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Leonard Epstein, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Medication Adherence [ Time Frame: 3 months ]
    The investigators will measure medication adherence through MEMS and pill count data
  • Prospective memory [ Time Frame: 3 months ]
    Prospective memory ability will be assessed through a computer-based prospective memory task
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Medication Adherence [ Time Frame: 3 months ]
    We will measure medication adherence through MEMS and pill count data
  • Prospective memory [ Time Frame: 3 months ]
    Prospective memory ability will be assessed through a computer-based prospective memory task
Change History Complete list of historical versions of study NCT04157673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Delay Discounting [ Time Frame: 3 months ]
    Participants' impulsivity will be assessed through a computer-based decision-making task
  • Working Memory [ Time Frame: 3 months ]
    Working memory will be assessed through a brief computer-based task
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
Official Title  ICMJE Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
Brief Summary Determine if a 6-week intervention consisting of future-thinking improves different facets of memory/executive function and/or decision-making.
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 3-month 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study is an experimental between-subjects design; participants will be randomized to Episodic Future Thinking (EFT) or a health informational control group (IC).
Masking: Single (Participant)
Masking Description:
Participants will not be informed of the group that they are randomly assigned until the completion of the study.
Primary Purpose: Treatment
Condition  ICMJE Medication Adherence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Episodic Future Thinking
    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 a 6-week 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.
    Intervention: Behavioral: Episodic Future Thinking
  • Active Comparator: Information Control Group
    The control group is called the information control group (IC), which consists of participants learning information relating to pre-diabetes or type 2 diabetes, and then generating sentences about this information, describing what they found useful or interesting about it. These sentences mirror the experience of engaging in episodic future thinking, except they lack the prospective and episodic components.
    Intervention: Behavioral: Episodic Future Thinking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04157673
Other Study ID Numbers  ICMJE FWA00008824
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leonard Epstein, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account State University of New York at Buffalo
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP