Trial Outcomes & Findings for Imagine to Remember: Improving Medication Adherence in Pre- and Type 2 Diabetes (NCT NCT04157673)

Last Updated: 2024-05-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

15 weeks

Results posted on

2024-05-21

Participant Flow

Participants completed a screening session prior to baseline period (n =7), in which they completed baseline measures of delay discounting, prospective memory tasks, and medication adherence. 4 participants were eligible and were assigned a baseline time-length (6-, 8- or 10- weeks). Participants were randomized to a baseline time length prior to baseline measurement. Data will be reported in aggregate, rather than by arm (baseline length) due to confidentiality concerns (as n = 1 for 2 arms).

Participant milestones

Participant milestones
Measure	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 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. 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Episodic Future Thinking n=4 Participants 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. 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. Data will be reported in aggregate, rather than by arm (baseline length) due to confidentiality concerns (as n = 1 for 2 arms).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Male	1 Participants n=5 Participants
Sex/Gender, Customized Female	2 Participants n=5 Participants
Sex/Gender, Customized Non-binary	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Baseline Medication Adherence	57.1 Percent n=5 Participants

PRIMARY outcome

Timeframe: 15 weeks

Population: Data will be reported in aggregate, rather than by arm (baseline length) due to confidentiality concerns (as n = 1 for 2 arms).

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=4 Participants 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. 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.
Medication Adherence Last week of Baseline to first week of treatment	34 percent change Standard Deviation 28
Medication Adherence Last week of baseline to last week of treatment	42 percent change Standard Deviation 36

PRIMARY outcome

Timeframe: 15 weeks

Population: Data will be reported in aggregate, rather than by arm (baseline length) due to confidentiality concerns (as n = 1 for 2 arms).

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.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=4 Participants 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. 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.
Prospective Memory	0.083 Number correct Standard Deviation 0.104

SECONDARY outcome

Timeframe: 15 weeks

Population: Data will be reported in aggregate, rather than by arm (baseline length) due to confidentiality concerns (as n = 1 for 2 arms).

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.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=4 Participants 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. 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.
Delay Discounting	0.355 proportion max reward x proportion delay Standard Deviation 0.295

Adverse Events

Episodic Future Thinking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leonard H. Epstein, PhD

University at Buffalo

Phone: 7168293400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place