- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157673
Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
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 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.
|
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 baseline period.
|
EXPERIMENTAL: Episodic Future Thinking introduced at 8 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 6-week period following a 8-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.
|
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 8-week baseline period.
|
EXPERIMENTAL: Episodic Future Thinking introduced at 10 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 4-week period following a 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.
|
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 10-week baseline period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Adherence
Time Frame: 3 months
|
The investigators will measure medication adherence through MEMS and pill count data
|
3 months
|
Prospective memory
Time Frame: 3 months
|
Prospective memory ability will be assessed through a computer-based prospective memory task
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay Discounting
Time Frame: 3 months
|
Participants' impulsivity will be assessed through a computer-based decision-making task
|
3 months
|
Working Memory
Time Frame: 3 months
|
Working memory will be assessed through a brief computer-based task
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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