An interventional study of iTAB-CV in Hypertension and Bipolar Disorder, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Supportive care
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 38 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Case Western Reserve University is the lead sponsor of 161 studies on the registry; 29 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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. Stage 1 will last one month. In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 2, 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. Stage 2 will last one month.
Behavioral: iTAB-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.
Also known as: Individualized Texting for Adherence Building-CV
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)
Change in Systolic Blood Pressure
Time frame: change from Screen (Week 0) to V2 (week 12)
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)
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)
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.
| Milestone | iTAB-CV |
|---|---|
| Started | 38 |
| Completed | 38 |
| Not completed | 0 |
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.
| percentage of days with missed doses | Whole Sample |
|---|---|
| Screen visit antihypertensive TRQ (past week) | 42.86 ± 23.15 |
| V2 (week 12) antihypertensive TRQ (past week) | 21.24 ± 17.95 |
| mmHg | Whole Sample |
|---|---|
| Screen visit systolic blood pressure | 144.81 ± 15.46 |
| V2 (12 week) systolic blood pressure | 136.02 ± 17.77 |
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.
| percentage of days with missed doses | Whole Sample |
|---|---|
| Screen visit bipolar medication TRQ (past week) | 43.95 ± 27.27 |
| V2 (12 week) bipolar medication TRQ (past week) | 25.86 ± 23.01 |
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.
| percentage of medications missed | Whole Sample |
|---|---|
| Baseline visit antihypertensive eCAP (past week) | 37.70 ± 28.19 |
| V2 (12 week) antihypertensive eCAP (past week) | 34.75 ± 28.88 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iTAB-CV | 0/38 (0%) | 9/38 (23.7%) | 0/38 (0%) |
| Event | iTAB-CV |
|---|---|
| suicidal thoughtsPsychiatric disorders | 2/38 |
| stomach painGastrointestinal disorders | 1/38 |
| Voluntary alcohol rehab at VASocial circumstances | 1/38 |
| diverticulitisGastrointestinal disorders | 1/38 |
| kidney stonesRenal and urinary disorders | 1/38 |
| high blood pressureBlood and lymphatic system disorders | 1/38 |
| hyperglycemiaBlood and lymphatic system disorders | 1/38 |
| swollen legsGeneral disorders | 1/38 |
| Age, Continuous(years) | iTAB-CV |
|---|---|
| Mean | 51.53 ± 9.06 |
| Sex: Female, Male(Participants) | iTAB-CV |
|---|---|
| Female | 20 |
| Male | 18 |
| Ethnicity (NIH/OMB)(Participants) | iTAB-CV |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 36 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | iTAB-CV |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 28 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | iTAB-CV |
|---|---|
| United States | 38 |
| Years of education(years) | iTAB-CV |
|---|---|
| Mean | 13.18 ± 2.69 |
| Employment(Participants) | iTAB-CV |
|---|---|
| Full time/homemaker | 1 |
| Part time | 3 |
| Unemployed, but expected to work by self or others | 6 |
| Disabled | 28 |
| Bipolar disorder type(Participants) | iTAB-CV |
|---|---|
| Bipolar Disorder Type I | 28 |
| Bipolar Disorder Type II | 10 |
10 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Mar 2017 to primary completion in Jun 2018, 14 months.
Results were first posted in Dec 2019, 1 year 6 months after primary completion.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 14 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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