Imagine To Remember: An Episodic Future Thinking Intervention To Improve Medication Adherence in Patients With Type 2 Diabetes Part 2

Methods

Participants

Potential participants were recruited using a local Research Match database, as well as through notices in our Clinical and Translational Research Center and notices on social media sites for people with prediabetes or type 2 diabetes who were interested in improving their medication adherence. 

The relationship between people with type 2 diabetes and memory is a topic of great concern, but regardless of their memory performance, people with diabetes should be encouraged to maintain a positive attitude.

People with diabetes are more susceptible to problems with attention and memory. Therefore, research shows that high blood sugar levels not only affect people's brain structure and function but also lead to cognitive decline and decline. However, this does not mean that patients with diabetes have no memory, but that they must work harder to maintain good physical and mental health and a positive attitude.

Research shows that engaging in moderate exercise, improving diet, and developing good sleep habits can have a positive impact on improving cognitive and memory function in people with diabetes. In addition, behaviors such as not smoking and limiting alcohol consumption can also reduce the risk of memory loss in people with diabetes.

It's worth mentioning that diabetes can be treated and managed with medications, and controlling blood sugar levels can also help improve cognitive and memory function. Therefore, it is recommended that diabetic patients actively cooperate with the doctor's treatment plan in daily life to maintain stable blood sugar levels.

Finally, we should convey a positive message to all diabetic patients. Diabetes does not mean that memory will be damaged. As long as the correct methods are mastered, diabetic patients can have a healthy and beneficial brain and process just like normal people. of pleasure. It can be seen that we need to improve memory, and Cistanche deserticola can significantly improve memory, because Cistanche deserticola has antioxidant, anti-inflammatory, and anti-aging effects, which can help reduce oxidation and inflammatory reactions in the brain, thereby protecting the health of the nervous system. In addition, Cistanche deserticola can also promote the growth and repair of nerve cells, thus enhancing the connectivity and function of neural networks. These effects can help improve memory, learning, and thinking speed, and may also prevent the development of cognitive dysfunction and neurodegenerative diseases.

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Inclusion criteria were a diagnosis of type 2 diabetes or prediabetes, with high blood pressure or high cholesterol, and currently prescribed at least one medication for blood glucose regulation, high blood pressure, or high cholesterol, and met non-adherence criteria of less than 80% non-adherence during comprehensive baseline assessment. Exclusion criteria included unmanaged psychological disorders, neurological conditions, pregnancy, substance abuse issues, intellectual impairments or learning disabilities, not having access to the internet, and not experiencing a recent stressful major life event, which could influence prospective memory.

Multiple Baseline Design

Multiple baseline designs are part of a family of single-case experimental designs. Multiple baseline designs collect repeated measurements on a small number of participants and implement the treatment in a staggered fashion. 

If the outcome variables change only after treatment is introduced, and not during extended baseline, the change can be attributed to the introduction of treatment. The more replications of this effect, the stronger the case for the treatment to have influenced the outcome. 

The goal in single-case experimental designs in general, and multiple baseline designs in particular, is a functional analysis of the relationship between treatment and outcome for the people who are studied.30,31 The multiple baseline design used in this study included two phases, a baseline phase and an EFT treatment phase. 

An important aspect of of multiple baseline designs is that the measures during each phase provide a good estimate of that behavior under those conditions, and as such the length of the phase depends on the observation of relative stability or a change in the opposite direction from treatment effects. 

During baseline, medication adherence was objectively measured as a screen for identifying people who were objectively nonadherent, with no indication that participants were improving as a function of repeated measurement. 

Participants who were not found to be nonadherent during baseline, or who improved as a function of repeated measurement without treatment were not included in treatment. 

After stable baselines were established for all participants, treatment was then introduced in a staggered fashion, with people randomized to when treatment began.32 This randomization removes any potential bias that may occur if people were asked when they are ready to begin, or if treatment is started based on how rapidly someone meets baseline criteria. After treatment is introduced, it should be carried out long enough to establish stability or clear trends in the direction of change. 

The statistical analyses to be presented are designed to assess baseline trends, the stability of baseline and EFT data, and phase changes from baseline to EFT. Single-case experimental designs are ideally suited for early-phase translational research to explore whether a basic cognitive neuroscience method, in this case, EFT, can be translated into an effective intervention. 

If the single-case design shows a functional relationship between treatment and outcome, the next step would be a fully powered, randomized controlled study designed to compare the new treatment to established methods.

Measures

Medication Adherence

MEMS

Medication Event Monitoring Systems (MEMS) were used to assess medication adherence. Data was downloaded from the MEMS at the Assessment sessions, as well as at the intervention sessions. The MEMS provides data on how frequently the medication bottle was opened and the times at which the medication bottle was opened. 

The MEMS is considered the gold standard for measuring medication adherence and has been shown to correlate with pill count data.33–35 

Self-Reported Medication Adherence To determine participants' eligibility and which medications to study, self-reported medication adherence was assessed at the Baseline/Screening session. 

Participants were asked, "Over the past 30 days, what percentage of the time did you take your (medication) as prescribed?" This rating was used to determine which medications to measure with the MEMS cap. Medications with the lowest rating of adherence were measured.

Prospective Memory Tasks

Virtual Week

The Virtual Week board game is a reliable and valid measure36 in non-clinical and clinical samples used to assess PM.36,37 This computerized task was completed by participants at the screening/baseline session and assessment sessions. 

Participants were presented with a board game paradigm, in which they simulated going through a "day" (represented by moving a token around the board). They were also instructed to complete different tasks throughout the day or when other events occurred (eg, take your antibiotics when you eat breakfast; use your asthma inhaler when the clock reads 11 am). 

Participants completed three "days" of this task and, in total, were asked to complete 30 tasks. In addition to being scored on their ability to complete each task, participants were also scored on completing time-based PM tasks and event-based PM tasks. 

Data was also collected on whether participants completed these tasks early or late. Correct in this task is defined as after the dice roll that initiated the task but before the next dice roll if the task is event-based or within ten seconds if the task is time-based. 

Early is defined as anything before the target time and anything before the dice roll of that task. Late is defined as anything after the next dice roll for that task or ten seconds after the allotted time. 

Additionally, during the assessment sessions, participants read through their EFT cues before beginning each "day." As this task was administered three times throughout the study, different versions of the task were presented to eliminate practice effects. Participants' scores are the percent of tasks correct out of 30 tasks. Higher scores indicated better prospective memory.

Event-Based PM Task

An event-based prospective memory task was also administered. This task has acceptable reliability reliability38 and extensive validation about theoretically derived predictions,39 including relationships with medication adherence.40,41 

In the version of the task we used, participants were asked to complete an extra task (clicking the mouse an extra time when certain words appeared) while simultaneously finding target words on a word list.40 

This task was completed at the screening/baseline session, as well as the assessment sessions. Participant scores were from 0 to 8, with 8 being the highest score attainable. Higher scores were indicative of better prospective memory.

Delay Discounting Task

Adjusting Amount Delay Discounting Task

All participants completed an adjusting amount delay discounting task at the baseline/screening session and each assessment session.12 During this task, participants chose between receiving a larger amount of money at a future time point (1 week, 1 month, 3 months, 6 months, 1 year) or a smaller amount of money now (eg, "Would you rather have $50 now or $100 in 1 week?). 

The amount of money offered "now" is adjusted based on the participant's initial response. For each participant, indifference points, or the amount of money offered now that was just as appealing to them as $100 at a future time point, were established. During the assessment sessions, participants read through their EFT cues before completing the task.

Working Memory Task

Backward Corsi Tapping Task

The Backwards Corsi Tapping Task was used to assess short-term visuospatial working memory at the screening/ baseline session42,43 as diabetes can impair working memory,44 which we have shown is related to EFT.28,45 The Corsi Block Tapping Task has acceptable reliability and validity in older adults.46 

This computerized task involved participants viewing a series of squares on a computer screen. The squares on the screen lit up one at a time, and participants were asked to copy the pattern that the squares lit up in the reverse order by clicking the squares with their mouse. 

This task began with the two squares lighting up per trial and progressively got longer as participants completed each trial. There were two trials per trial length. Following participants getting two trials of the same length wrong, the task terminated.

Procedures

Participants were randomized into one of three staggered baselines, 6, 8, or 10 weeks. Intervention for all participants continued up to week 15. The study began before the COVID-19 pandemic, and one participant had an in-person screening appointment, but all other appointments including case management were done via the video conferencing software Zoom (Zoom Video Communications, Inc., 2016). 

The study was approved by the IRB at the University at Buffalo, and guidelines outlined in the Declaration of Helsinki were followed. The trial was registered at NCT04157673. 

The study ran from February 2020 to October 2020. All participants provided informed consent. Deidentified medication, memory, and delay discounting data will be available from Dr. Epstein (lhenet@buffalo.edu) upon request for at least 5 years after study publication.

Screening and Baseline

Initially, eligible participants were invited to complete a screening/baseline session. At this session, participants were shown a brief orientation, detailing the responsibilities of eligible participants, and they answered questions regarding demographics, alcohol and drug use, and their medication adherence. Additionally, participants completed prospective memory36,37,40 and delay discounting12 tasks. 

Eligible participants were mailed up to 3 medication event monitoring systems (MEMS, AARDEX, Zurich, Switzerland) caps, depending on how many medications they were prescribed for blood glucose regulation, hypertension, and hyperlipidemia. Upon receiving the MEMS caps, the baseline phase of the study began. The baseline phase was conducted for at least 6 weeks for all participants to determine participants' medication adherence and to allow for any effects of using the MEMS cap on adherence to wear off, which has been shown to last for 40 days.47 

Any participant who improved adherence just due to monitoring would not be eligible for the study. Eligibility criteria were set at less than 80% adherence over the baseline period.35,48,49

Intervention

After the 6-week baseline, research staff completed a contact-free MEMS reading session, in which data from the MEMS caps were obtained. Participants whose medication adherence was below 80% per week were randomized into a 6-week baseline group, an 8-week baseline group, or a 10-week baseline group. 

The EFT intervention was adapted from our EFT intervention designed to reduce delay discounting in people with prediabetes24 to focus on improving prospective memory.19,20,50,51 The intervention had participants first create their EFT cues. Cue creation involved participants creating scenarios in which they successfully took their medications at future time points. 

Participants were instructed to write their cues in the present tense, include specific details, such as who they are with, where they are, and how they are feeling, and focus on the positive aspects of the event. Participants created five cues in this manner and were instructed to create cues for typical weekdays, typical weekends, and unusual days (eg when they are traveling). 

The cues were made bi-weekly; participants engaged with their EFT cues daily using a smartphone app52 that presented cues at set intervals, and cues could also be retrieved at the participant's discretion.

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