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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTAB-CV | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTAB-CV | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | change from Screen (Week 0) to V2 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Levin, PhD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center and Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30991908 | Derived | Levin JB, Sajatovic M, Rahman M, Aebi ME, Tatsuoka C, Depp C, Cushman C, Johnston E, Cassidy KA, Blixen C, Eskew L, Klein PJ, Fuentes-Casiano E, Moore DJ. Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. Psychiatr Serv. 2019 Jul 1;70(7):608-612. doi: 10.1176/appi.ps.201800482. Epub 2019 Apr 17. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Stage 1 lasts one month. Stage two of iTAB-CV includes the addition of customized context cues/reminders and immediate reinforcement for medication taking behavior in addition to 1 daily motivational mood rating. The number of texts per day will be determined based on the number of times a day that medications are prescribed (up to four a day). Stage two lasts one month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Baseline descriptives | Posted | Mean | Standard Deviation | percentage of days with missed doses | change from Screen (Week 0) to V2 (week 12) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iTAB-CV | Participants received 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stomach pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Levin | Case Western Reserve University | 2168445057 | jennifer.levin@uhhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2017 | Sep 4, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 16, 2017 | Sep 4, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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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.
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|
|
| 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. | change from Baseline (Week 4) to V2 (week 12) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| Employment | Count of Participants | Participants |
|
| Bipolar disorder type | Baseline diagnostic assessment of type of bipolar disorder. Bipolar I Disorder is defined by manic episodes that last at least 7 days, or by manic symptoms that are so severe that the person needs immediate hospital care. Usually, depressive episodes occur as well, typically lasting at least 2 weeks. Episodes of depression with mixed features (having depression and manic symptoms at the same time) are also possible. Bipolar II Disorder is defined by a pattern of depressive episodes and hypomanic episodes, but not the full-blown manic episodes described above. | Count of Participants | Participants |
|
| Age of hypertension diagnosis | Mean | Standard Deviation | years |
|
| Age of bipolar disorder diagnosis | Mean | Standard Deviation | years |
|
| hypertension-related hospitalizations | Number of hypertension-related hospitalizations over participant's lifetime. | Nineteen people endorsed having at least one hypertension-related hospitalization in their lifetime. Therefore, the median number of how many hospitalizations they had are based solely on those 19, to eliminate skewing of results of everyone who answered 0 lifetime hypertension-related hospitalizations. | Median | Full Range | occurrences |
|
| substance use-related hospitalizations | Number of hospitalizations related to substance use over the participant's lifetime. | Twelve people endorsed having at least one hypertension-related hospitalization in their lifetime. Therefore, the median number of how many hospitalizations they had are based solely on those 12, to eliminate skewing of results of everyone who answered 0 lifetime substance use-related hospitalizations. | Median | Full Range | occurrences |
|
| History of physical abuse | Count of Participants | Participants |
|
| History of sexual abuse | Count of Participants | Participants |
|
| Mental illness in the family | Count of Participants | Participants |
|
| Smokes cigarettes | Count of Participants | Participants |
|
| Median number of cigarettes smoked per day | Twenty-three people endorsed being a cigarette smoker. Therefore, the median number of how many cigarettes smoked per day is based solely on those 23, to eliminate skewing of results of everyone who answered they are not cigarette smokers. | Median | Full Range | cigarettes per day |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
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| Secondary | Change in Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | change from Screen (Week 0) to V2 (week 12) |
|
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| 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. | Missing data for one participants (i.e. n= 37). | Posted | Mean | Standard Deviation | percentage of days with missed doses | change from Screen (Week 0) to V2 (week 12) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of medications missed | change from Baseline (Week 4) to V2 (week 12) |
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| 0 |
| 38 |
| 9 |
| 38 |
| 0 |
| 38 |
| Voluntary alcohol rehab at VA | Social circumstances | Systematic Assessment |
|
| diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| kidney stones | Renal and urinary disorders | Systematic Assessment |
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| suicidal thoughts | Psychiatric disorders | Systematic Assessment |
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| high blood pressure | Blood and lymphatic system disorders | Systematic Assessment |
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| hyperglycemia | Blood and lymphatic system disorders | Systematic Assessment |
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| swollen legs | General disorders | Systematic Assessment |
|
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| D001523 | Mental Disorders |