Bipolar Disorder, Hypertension
Conditions
Brief summary
This study will test an adherence intervention (iTAB-CV) delivered via interactive text messaging which first targets behavioral intent and then adds cues/reminders and reinforcement to form the habit of taking antihypertensives in non-adherent individuals with BD. Thirty eight individuals with BD and HTN being treated with evidence-based antihypertensive agents and mood stabilizing or antipsychotic medications who are non-adherent with their HTN medicine will be enrolled. This study uses a prospective cohort design with participants serving as their own control. Investigators will test the iTAB-CV intervention quantitatively for feasibility and acceptability as well as for efficacy in increasing adherence to antihypertensives, decreasing systolic blood pressure, and increasing adherence to BD medication.
Detailed description
This study will test an adherence intervention (iTAB-CV) delivered via interactive text messaging which first targets behavioral intent and then adds cues/reminders and reinforcement to form the habit of taking antihypertensives in non-adherent individuals with BD. Thirty eight individuals with BD and HTN being treated with evidence-based antihypertensive agents and mood stabilizing or antipsychotic medications who are non-adherent with their HTN medicine will be enrolled. This study uses a prospective cohort design with participants serving as their own control. Investigators will test the iTAB-CV intervention quantitatively for feasibility and acceptability as well as for efficacy in increasing adherence to antihypertensives, decreasing systolic blood pressure, and increasing adherence to BD medication. All study participants will be followed for a 3-month period. iTAB-CV, delivered via mobile phone, is intended to be a brief adjunct to standard primary care and mental health treatment. All individuals will continue to receive treatment as usual with their regular provider(s). Individuals who meet eligibility criteria will have a 30 day run-in period in which their medication adherence will be measured with TRQ and MEMS but without an additional intervention. Following the run-in period, Stage 1 of the iTAB-CV intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month of iTAB-CV, participants will receive alternating daily texts with psychoeducational and motivational content once daily and a daily mood rating request to both monitor their mood and to determine engagement with the iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1. Assessments that include evaluation of treatment adherence, psychiatric symptoms, self-efficacy for medication taking behavior, illness beliefs, medication attitudes, and habit strength for both antihypertensive and BD medications will be conducted at four time points over a 3-month time period (screening, baseline/week 4, week 8, and week 12). Blood pressure will be measured at each of the four contacts. Individuals who drop out of the intervention, and who agree, will be followed up with outcomes assessments over the same 3-month time period that they would have been evaluated had they remained in the study. About one month after study completion, a member of the research team will call each participant and ask questions about their bipolar and blood pressure medication taking habits.
Interventions
BEHAVIORALiTAB-CV
Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention. In the second stage for the following month, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.
Sponsors
Case Western Reserve University
Study design
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Following a 30 day run-in period, Stage 1 of the iTAB-CV intervention will be introduced. A member of the study team will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month of iTAB-CV, participants will receive alternating daily texts with psychoeducational and motivational content once daily and a daily mood rating request to both monitor their mood and to determine engagement with the iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants will have a clinical diagnosis of BD for at least 2 years as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (52) 2. Have stage 1 or 2 HTN with a systolic pressure ≥130 3. Carry a diagnosis of HTN per patient self-report ≥ 6 months prior to enrollment 4. Have been prescribed at least one regularly scheduled antihypertensive medication for ≥ 3 months since diagnosis 5. Have self-reported poor adherence to antihypertensive medication defined as at least 20% of days with missed doses for at least one antihypertensive in either the past week or past month as identified by the Tablets Routine Questionnaire (TRQ). 6. Be able to participate in psychiatric interviews
Exclusion criteria
1. Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales 2. Unable or unwilling to give written, informed consent to study participation 3. Under the age of 21 4. In the interest of patient safety, individuals who are at high immediate risk for suicide will be excluded from study participation. The suicide risk assessment will be informed by standardized assessments of psychiatric symptoms and the Mini-International Neuropsychiatric Interview (MINI). In the event that a potential study participant is determined to be at high risk for suicide, that individual will not be enrolled and the study staff will immediately implement procedures for the safety of the individual. Once such individuals are deemed stable, they may be once again considered for inclusion in the research. 5. Individuals who are monolingual, non-English speaking will be excluded. Given the relatively small sample size in the proposed study, it would not be practical to conduct sub-group analyses. Also, the study assessment tools and the texting intervention are not available in other languages and would be impractical to develop. Based upon our BD adherence work, which drew upon a population similar to the proposed trial, there were no potential subjects who were excluded from the studies due to inability to speak English. 6. Illiterate participants will be excluded because reading is an essential skill required to complete self-report questionnaires administered during the study as well as to respond to the text messages which make up the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ) | change from Screen (Week 0) to V2 (week 12) | This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | change from Screen (Week 0) to V2 (week 12) | — |
| Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ) | change from Screen (Week 0) to V2 (week 12) | This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single index drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included. |
| Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP) | change from Baseline (Week 4) to V2 (week 12) | Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as taken if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription. |
Countries
United States
Participant flow
Recruitment details
Thirty eight individuals with bipolar disorder (BD) and hypertension (HTN) being treated with evidence-based antihypertensive agents and mood stabilizing or antipsychotic medications who are nonadherent with their HTN medicine will be enrolled by referral. This phase uses a prospective cohort design with participants serving as their own control.
Pre-assignment details
After providing informed consent, all participants will undergo screening followed by a 30-day run-in period in which adherence will be measured using eCAP and self-report. During the 30-day run-in period, participants will continue to receive care as usual and serve as their own control with no intervention.
Participants by arm
| Arm | Count |
|---|---|
| iTAB-CV In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention.
iTAB-CV Stage 1: Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | iTAB-CV |
|---|---|
| Age, Continuous | 51.53 years STANDARD_DEVIATION 9.06 |
| Age of bipolar disorder diagnosis | 31.95 years STANDARD_DEVIATION 13.46 |
| Age of hypertension diagnosis | 36.95 years STANDARD_DEVIATION 15.66 |
| Bipolar disorder type Bipolar Disorder Type I | 28 Participants |
| Bipolar disorder type Bipolar Disorder Type II | 10 Participants |
| BMI | 22.15 kg/m^2 STANDARD_DEVIATION 9.4 |
| Employment Disabled | 28 Participants |
| Employment Full time/homemaker | 1 Participants |
| Employment Part time | 3 Participants |
| Employment Unemployed, but expected to work by self or others | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| History of physical abuse No | 18 Participants |
| History of physical abuse Yes | 20 Participants |
| History of sexual abuse No | 18 Participants |
| History of sexual abuse Yes | 20 Participants |
| hypertension-related hospitalizations | 3.16 occurrences |
| Median number of cigarettes smoked per day | 6.00 cigarettes per day |
| Mental illness in the family No | 8 Participants |
| Mental illness in the family Yes | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 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 | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 18 Participants |
| Smokes cigarettes No | 15 Participants |
| Smokes cigarettes Yes | 23 Participants |
| substance use-related hospitalizations | 3.00 occurrences |
| Years of education | 13.18 years STANDARD_DEVIATION 2.69 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 9 / 38 |
Outcome results
Primary
Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)
This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.
Time frame: change from Screen (Week 0) to V2 (week 12)
Population: Baseline descriptives
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Sample | Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ) | Screen visit antihypertensive TRQ (past week) | 42.86 percentage of days with missed doses | Standard Deviation 23.15 |
| Whole Sample | Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ) | V2 (week 12) antihypertensive TRQ (past week) | 21.24 percentage of days with missed doses | Standard Deviation 17.95 |
p-value: <0.001Friedman test
Secondary
Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)
Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as taken if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
Time frame: change from Baseline (Week 4) to V2 (week 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Sample | Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP) | V2 (12 week) antihypertensive eCAP (past week) | 34.75 percentage of medications missed | Standard Deviation 28.88 |
| Whole Sample | Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP) | Baseline visit antihypertensive eCAP (past week) | 37.70 percentage of medications missed | Standard Deviation 28.19 |
p-value: 0.89ANOVA
Secondary
Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)
This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single index drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included.
Time frame: change from Screen (Week 0) to V2 (week 12)
Population: Missing data for one participants (i.e. n= 37).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Sample | Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ) | Screen visit bipolar medication TRQ (past week) | 43.95 percentage of days with missed doses | Standard Deviation 27.27 |
| Whole Sample | Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ) | V2 (12 week) bipolar medication TRQ (past week) | 25.86 percentage of days with missed doses | Standard Deviation 23.01 |
p-value: <0.001Friedman test
Secondary
Change in Systolic Blood Pressure
Time frame: change from Screen (Week 0) to V2 (week 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Whole Sample | Change in Systolic Blood Pressure | Screen visit systolic blood pressure | 144.81 mmHg | Standard Deviation 15.46 |
| Whole Sample | Change in Systolic Blood Pressure | V2 (12 week) systolic blood pressure | 136.02 mmHg | Standard Deviation 17.77 |
p-value: <0.001ANOVA