Outcomes of Psychoeducation Combined with a Text Messaging Adherence Intervention in Individuals with Hypertension and Bipolar Disorder

Abstract

Objective:

This study evaluated the feasibility, acceptability, and preliminary efficacy of psychoeducation plus an automated text-messaging intervention (iTAB-CV) to improve adherence for antihypertensives and bipolar disorder medication.

Methods:

Following a psychoeducation program, iTAB-CV was administered for two months. In month one, participants received one educational/motivational and one mood rating text daily. In month two, medication reminders were added.

Results:

The sample (n=38) was 74% African-Americans, 53% women, with a mean age of 51.53±9.06. Antihypertensive non-adherence decreased from 43%±23% to 21%±26% at 12 weeks [χ² = 34.6, df= 3, p< 0.001]. SBP decreased from 144.8±15.5 mmHg to 136.0±17.8 mmHg (χ² = 17.6, df=3, p< 0.001). Retention was 100%.

Conclusions:

In this uncontrolled trial, participants were highly engaged and medication adherence and reduced SBP were sustained following psychoeducation plus iTAB-CV. Since iTAB-CV is automated and delivered remotely, it has potential to reach a large and challenging population.

Between 25–45% of those living with bipolar disorder have hypertension. Poor adherence to antihypertensives occurs in 50–80% of patients with bipolar disorder, likely contributing to premature mortality and a shortened life expectancy.¹

No single intervention has strong evidence for improving medication adherence² and the few existing bipolar disorder adherence interventions do not address medical comorbid conditions.² Therefore, novel approaches to improving hypertension adherence are needed in bipolar disorder.

There is growing evidence that mobile health tools (m-Health) positively impact behavior change. A bidirectional text-messaging system entitled Individualized Texting for Adherence Building (iTAB) has been used in complex populations where medication adherence rates are both suboptimal and critical for health outcomes³ but has not yet been used with co-occurring bipolar disorder and hypertension.

The current project is built on an expanded version of the Attitude-Social Influence-Efficacy (ASE)⁴ model of behavioral intent and change (see online supplement) and posits that a successful intervention must remediate for prospective memory deficits with reminders and include reinforcement to achieve a consistent medication-taking habit.

iTAB-Cardiovascular (iTAB-CV) was developed using qualitative methodology.⁵ The current study evaluated psychoeducation + iTAB-CV for feasibility, acceptability, and preliminary efficacy.

Methods

The study used a prospective cohort design (see online supplement) and ran from April, 2017 to July, 2018. All eligible participants received psychoeducation followed by iTAB-CV and continued with their primary care and mental health treatment providers.

Individuals were recruited at a major academic medical center located in an urban center. Inclusion criteria included: 1) a clinical diagnosis of bipolar disorder for ≥2 years as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI);⁶ 2) a diagnosis of hypertension per patient self-report ≥6 months prior to enrollment; 3) systolic blood pressure (SBP) ≥130 at screen; 4) been prescribed ≥1 regularly-scheduled antihypertensive medication for ≥3 months since diagnosis; 5) missing 20% or more of ≥1 antihypertensive; and 6) able to participate in psychiatric interviews. Participants also had to be willing to respond to text messages and utilize an electronic medication tracking device over the 90-day study period.

Participants were excluded if they were under the age of 21 or at high immediate risk for suicide.

Participants received psychoeducation about the symptoms, risks, and the important roles of medication in both antihypertensive and bipolar disorder treatment. The information was gathered from publically available information disseminated by the American Heart Association on hypertension and the National Institute of Mental Health on bipolar disorder. This information was reviewed for accuracy and understandability by experts in the area of internal medicine and psychiatry. The psychoeducation portion was delivered individually face-to-face and took approximately 15–20 minutes.

The study was approved by the institution’s IRB and all participants provided written informed consent.

In month one of iTAB-CV, participants received one daily text message with psychoeducational/motivational content. Participants responded whether the message was helpful or not (see online supplement for text categories, sample stems, sample text exchange). Participants also received one daily mood rating scale. In month two, specific medication reminders and immediate reinforcement were added and daily mood rating continued. Percent of answered texts was used as a proxy for engagement. Responses were monitored by an automated system.

Prior to the start of iTAB-CV, participants could decline stems from a list of 42 pre-written reminders in seven categories derived from the ASE model, the qualitative study and consultation with clinical experts. Participants then reviewed 16 reinforcement stems (e.g., “You’re doing wonderfully with taking your meds!”) with the option to remove and created their own adherence reminders and reinforcement messages.

Reminder messages were scripted to be sent up to four times a day via a central server based on the number of medication doses for each participant. The system had protections against multiple or inaccurate responses. After three consecutive days of missed messages, the automated system sent an outreach message. The research assistant also had real-time access to participant response logs to identify technical problems.

Adherence Measures:

1. Tablets Routine Questionnaire (TRQ): A self-report measure of the percentage of days with missed doses of a given medication in the past week and month.⁷ Adherence was assessed for each regularly scheduled antihypertensive prescribed for ≥3 months. For those taking more than one antihypertensive medication, an average was calculated. Adherence was also assessed for each evidence-based regularly-scheduled maintenance bipolar disorder medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥3 months and an average was also calculated. PRN medications were not included.

2. eCAP: An objective measure of medication adherence recorded the number of bottle openings.⁸ The antihypertensive missed the most frequently in the past week went into the eCAP. If two medications were missed at the same frequency, the one dosed most frequently was chosen. Percent of doses taken was calculated and the direction of the eCAP data was then reversed so higher numbers indicated worse adherence.

Blood pressure was measured using an automated monitor. The average of three readings was recorded at each visit following a standardized protocol.

Bipolar symptoms were measured with the Brief Psychiatric Symptom Scale (BPRS),¹⁰ the Montgomery-Asberg Depression Rating Scale (MADRS),¹¹ and the Young Mania Rating Scale (YMRS).¹²

The Self-Report Habit Index (SRHI) is a 12-item self-report measure of habit strength for taking medications.¹³ Higher scores indicate more automaticity and experience with a habit.

Treatment acceptability/satisfaction was measured via a self-report exit questionnaire and feasibility was evaluated by percentage of texts answered. All measurements were taken at screening, baseline (4-week), V1 (8-week), and V2 (12-week) follow-up (aside from eCAP which was distributed after screen).

Friedman’s tests assessed significance of change in adherence for past week TRQ and eCAP and change in SBP over the course of the study. Non-parametric statistics were run when analyzing adherence and SBP. Post-hoc analyses used a Bonferroni correction. Change in eCAP was computed by subtracting baseline values from V2. Change in habit strength (SHRI) and TRQ were computed by subtracting screen values from V2 values. One-way repeated measures

ANOVAs were run for symptom measures and SRHI. Spearman correlations were run between adherence, habit strength, and SBP.

Results

Thirty-eight participants were enrolled and 100% completed the study with no attrition overall (see CONSORT diagram in online supplement).

Demographic and clinical variables are presented in the online supplement. Mean age of the sample was 51.5±9.1 years; 53% were women and 74% were African-American. SBP at screen was 144.8±15.5 mmHg. Body mass index was 22.15±9.4, and 61% of the sample were smokers. Five individuals (13%) had a stroke history, 6 (16%) heart disease, 22 (58%) high cholesterol, and 15 (40%) diabetes. Mean number of medications at screen was 1.5±0.7 and 1.3±0.5) for hypertension and bipolar disorder, respectively. Treatment adherence at screen averaged 43%±23% and 45%±28% of days with missing doses in the past week for hypertension and bipolar medications, respectively. Mean BPRS scores at screen were in the mild range, mean MADRS scores were at the low end of the moderate depressive range, and mean YMRS scores were in the normal range. There was a significant improvement in baseline TRQ for antihypertensives and bipolar medications, with past week TRQ of 21%±19% and 21%±26%, respectively.

Acceptability and Adherence: In stage 1, mean number of educational/motivational texts sent was 31.52± 4.9 and mean percentage of valid responses was 66%±33%. Of those responses, 95%± 7.1% of the messages were deemed helpful. In stage 2, mean number of medication reminders was 50.2±15.4 and mean percentage of valid responses was 67%±28%. Mean percentage of valid responses to mood messages was 62%±35% and 56%±29%) for stage 1 and 2, respectively.

Primary outcome: Proportion of missed medication decreased from screen to baseline and then was maintained throughout the study for both antihypertensive and bipolar medications (see online supplement). Antihypertensive and bipolar drug adherence improvement was significant between screen and baseline, screen and V1, and screen and V2 for both past week and month. There were no significant differences between any of the time points for eCAP at either past week or past month.

Secondary Outcomes: There was a statistically significant difference in SBP at the different time points, χ²=17.61, df= 3, p <0.001. Post-hoc analyses revealed statistically significant reduction in SBP from screen (M=144.8±15.5; Mdn=141.3) to baseline (M=133.0±17.9; Mdn=132.3) and screen to V1 (M=134.8±=19.6; Mdn=129.5). There were no significant correlations between change in eCAP from baseline to V2 and change in hypertension SRHI from screen to V2 (r_s=0.23, df= 33, p=0.19) or between change in eCAP and change in TRQ from screen to V2 (r_s= −0.26, df= 33 p=0.13). However, there was a significant correlation between change in hypertension SRHI between screen and V2 and change in past week hypertension TRQ (r_s= −0.37, df= 36, p=0.02).

There was a statistically significant difference between BPRS scores between screen and each follow-up time point. The MADRS significantly lowered from screen to V2. YMRS scores did not significantly decrease. The results show that self-reported hypertension habit strength increased between all combinations of time points except for between V1 and V2.

All time points were significant or trending significance when correlating hypertension SRHI and TRQ (screen= r_s= −0.40, df= 36, p= 0.01; BL= r_s= −0.32, df= 36, p= 0.053; V1= r_s= −0.43, df= 36, p< 0.01; V2= r_s= −0.44, df= 36, p< 0.01).

Exit interviews indicated 79% of participants agreed or strongly agreed that the benefit of receiving texts outweighed the hassle, 87% agreed or strongly agreed that iTAB-CV texts were useful, 100% agreed or strongly agreed that they would recommend iTAB-CV to others, and 95% either agreed or strongly agreed that if given the chance to continue iTAB-CV after study end, they would.

Discussion

Our results support the feasibility, acceptability and preliminary potential efficacy of psychoeducation combined with a personalized text-messaging intervention (iTAB-CV) for maintaining adherence with both antihypertension and bipolar medications in a high-risk comorbid sample. Managing patients with psychiatric and medical comorbidity represents a significant challenge for clinicians. Encouragingly, patients with poorly controlled blood pressure and bipolar disorder in this pilot were highly engaged in this low-resource, remotely-delivered intervention, responding to a majority of the texts and finding the educational/motivational texts to be helpful. Furthermore, 100% of participants completed the study, particularly notable given their psychiatric diagnoses and acknowledged poor adherence to medical treatment at study start. The large percentage of African Americans in our sample makes the results distinctive as African Americans tend to be under-represented in clinical trials and have higher rates of uncontrolled hypertension.¹⁴ While findings need to be interpreted cautiously given the uncontrolled methodology, psychoeducation + iTAB-CV has potential to be a practical and scalable approach to help high-risk patients engage in managing their hypertension.

Self-reported medication-taking behavior improved from screen to baseline and then was maintained for both types of medications. The habit of taking medication also became stronger throughout the study and both SBP and psychiatric symptoms improvements were maintained, suggesting habit formation is a foundational feature of medication adherence. These results are consistent with a recent meta-analysis showing mobile text messaging doubles the odds of medication taking.¹⁵ To our knowledge, no studies to date have evaluated such an intervention in individuals with comorbid hypertension and bipolar disorder.

As in previous iTAB trials with other patient populations,³ the iTAB-CV results support a high level of patient engagement which may have resulted from personalizing message stems and reinforcers, removing content, and choosing windows of time to receive messages. There may be specific advantages of implementing personalized text messaging for medication adherence support into clinics which serve individuals with chronic mental illness as it makes them feel cared about and recognizes the importance of both mental and physical health.

The iTAB-CV approach is consistent with the trend for psychiatric patients seeking personalized and technology-driven care. In the course of conducting the trial, the investigators identified future refinements that could enhance impact and acceptability. Future text systems could personalize the frequency of messages such that messages taper off when adherence increases and return with waning adherence. If iTAB-CV was integrated into routine clinical care, real-time adherence information could be directed to prescribing clinicians and inform medical decision-making. Clinicians who are certain that medications are being ingested regularly may use that information in their prescribing decisions. Adherence information might also make treatment more efficient by avoiding unnecessary drug switches, improving the clinician-patient treatment alliance by helping both parties see the link between medication-taking and blood pressure response with a given medication or course of treatment.

Limitations to consider include not being a controlled study, not having eCAP screening data to compare with self-report data since eCAP was started at baseline. Additionally, both self-reported medication adherence and SBP were significantly reduced from screen to baseline, presumably as a function of regression to the mean or given that they were participating in an adherence study (Hawthorne effect) and using an eCAP, which has been shown to independently impact adherence. However, while medication monitoring alone may be impactful, it is unlikely to sustain long-term adherence or impact clinical outcomes. As such, it’s promising that improvement in self-reported adherence remained throughout the course of the study and corresponded to lowered SBP. Furthermore, there are few downsides to implementing an intervention such as iTAB-CV on a large scale, as the text-messaging component seems to keep patients engaged over longer time periods with minimal burden for the provider or patient. Despite the limitations, this pilot feasibility and acceptability data provide a strong basis for carrying out an RCT with the above-noted improvements to the design.

Conclusions

m-Health interventions are becoming increasingly popular for self-management of chronic conditions and have the potential to impact key health behaviors including medication adherence, particularly in individuals with multimoribidty. This study suggests that daily contact via text messaging is both feasible and acceptable, and that text messaging in conjunction with psychoeducation appears to strengthen the automaticity of medication taking and has the potential to improve adherence and sustain lower SBP and mood symptoms. Larger-scale studies with rigorous control groups are necessary to determine the long-term efficacy of such interventions and to tease out the relative contribution of different elements. In sum, an approach that integrates m-Health with face-to-face care appears to improve medication adherence among those with psychiatric and medical comorbidity.