Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder (iTAB-CV RCT)
Bipolar Disorder, Non-Adherence, Medication, Hypertension
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria:
- Age range: from 21 to 80
- Have a clinical diagnosis of Bipolar Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
- Have elevated systolic blood pressure ≥130 at screening
- Have received a diagnosis of hypertension per patient self-report at least 6 months prior to enrollment
- Have been prescribed at least one regularly scheduled antihypertensive medicine for 3 or more months since diagnosis
- Be poorly adherent (defined as missing 20% or more of medication within either the past week or past month) with prescribed antihypertensive medication
- Have their own cellular phone in order to receive text messages as part of the intervention
Exclusion Criteria:
- Unable/unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
- Unable/unwilling to give written, informed consent to study participation
- 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, the Mini-International Neuropsychiatric Interview (MINI), and the Montgomery Asberg Depression Rating Scale (MADRS). Individuals with active suicidal ideation and recent suicide attempt or current intent and plan will be excluded from study participation. Individuals who score a ≥ 5 on item 10 of the MADRS will be considered to be at high risk for suicide, although individuals with MADRS scores lower than 5 could potentially be excluded if either the psychologist or psychiatrist PIs believe that the individual is at high immediate risk for suicide based upon other input or information. 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 that individual is no longer at risk, they may be rescreened for possibility enrollment in the study
- Individuals who are monolingual, non-English speaking will be excluded. Given the proposed sample sizes of the iTAB-CV + SM and SM alone treatment arms in the proposed study, it would not be practical to conduct sub-group analyses. Based upon our BD adherence work and RCT, 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. Hispanic individuals made up 3.6% of those enrolled
- Upper arm circumference > 50cm
Sites / Locations
- Case Western Reserve UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
iTAB-CV + Self Monitoring
Self Monitoring
iTAB-CV + Self Monitoring - High Intensity Booster
iTAB-CV + Self Monitoring - Low Intensity Booster
Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating
Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating
Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the high intensity booster group will start off receiving 1 reminder per day and taper down to 1 reminder per week over 2 months, in addition to self monitoring.
Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the low intensity booster group will receive 1 reminder per week for 2 months, in addition to self monitoring.