Improving medication adherence and lowering blood pressure in people with mood disorders
Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Mood Disorders.
This study is testing a new way to help people with bipolar disorder or depression remember to take their blood pressure medication by using text messages and self-monitoring to see if it can lower their blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04675593 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a personalized intervention combining interactive text messaging and self-monitoring to improve adherence to antihypertensive medication in individuals with bipolar disorder or major depressive disorder. The study will enroll 200 participants who struggle with medication adherence and have hypertension, assessing the effectiveness of the intervention over an 11-month period. Participants will be randomized into two groups: one receiving the full intervention and the other receiving self-monitoring alone. The goal is to enhance health outcomes in this vulnerable population by improving medication adherence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 80 with a diagnosis of bipolar disorder or major depressive disorder, elevated blood pressure, and a history of non-adherence to antihypertensive medication.
Not a fit: Patients who do not have a mood disorder or those who are not currently prescribed antihypertensive medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve blood pressure control and overall health in patients with mood disorders.
How similar studies have performed: Other studies have shown promise in using technology to improve medication adherence, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age range: from 21 to 80 * Have a clinical diagnosis of either Bipolar Disorder or Major Depressive Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) * Have elevated systolic blood pressure ≥130 at screening at least 2 different times during the screening period * 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 * Have difficulty with adherence to prescribed antihypertensive medication currently or in the past based on one of the following questions: Do you ever miss doses of your prescribed medications for high blood pressure? Or b. Do you ever try to manage your high blood pressure on your own without medication? * For those with MDD, currently being prescribed an antidepressant 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
Where this trial is running
Cleveland, Ohio
- Case Western Reserve University — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Levin, PhD — Case Western Reserve University
- Study coordinator: Jennifer Levin, PhD
- Email: jennifer.levin@case.edu
- Phone: 216-844-5057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.