Clinical trial NCT04157673: Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
Official title: Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a multiple-baseline single subject design; participants will be randomized to intervention at 6-week, 8-week, or 10-week.
Primary purpose: TREATMENT

Brief summary: Determine if an 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence
timeFrame: 15 weeks
measure: Prospective Memory
timeFrame: 15 weeks
Secondary outcomes:
measure: Delay Discounting
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
state: New York
Study officials:
References: