Medication Adherence
Conditions
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.
Interventions
BEHAVIORALEpisodic 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.
Sponsors
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants will not be informed of the group that they are randomly assigned until the completion of the study.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 15 weeks | 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 |
| Prospective Memory | 15 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delay Discounting | 15 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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.
Data will be reported in aggregate, rather than by arm (baseline length) due to confidentiality concerns (as n = 1 for 2 arms). | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Episodic Future Thinking |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Baseline Medication Adherence | 57.1 Percent |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 4 participants |
| Sex/Gender, Customized Female | 2 Participants |
| Sex/Gender, Customized Male | 1 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking | Medication Adherence | Last week of Baseline to first week of treatment | 34 percent change | Standard Deviation 28 |
| Episodic Future Thinking | Medication Adherence | Last week of baseline to last week of treatment | 42 percent change | Standard Deviation 36 |
Comparison: Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.p-value: 0.0002Mixed Models Analysis
Primary
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episodic Future Thinking | Prospective Memory | 0.083 Number correct | Standard Deviation 0.104 |
Comparison: Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.
Secondary
Delay Discounting
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Episodic Future Thinking | Delay Discounting | 0.355 proportion max reward x proportion delay | Standard Deviation 0.295 |