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Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder (iTAB-CV RCT)

Primary Purpose

Bipolar Disorder, Non-Adherence, Medication, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTAB-CV
Self-Monitoring
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

iTAB-CV + Self Monitoring

Self Monitoring

iTAB-CV + Self Monitoring - High Intensity Booster

iTAB-CV + Self Monitoring - Low Intensity Booster

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in the Tablet Routine Questionnaire (TRQ)
The TRQ item is a subject report of the percentage of prescribed medications not taken within the past month.
Change in systolic blood pressure (SBP)
Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure
Change in Adherence 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.

Secondary Outcome Measures

Change in Montgomery Asberg Rating Scale (MADRS) score
The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Change in engagement with iTAB intervention
Engagement will evaluated using the percentage of texts messages the subject responds to
Change in Beliefs About Medicines Questionnaire (BMQ) score
The BMQ assess beliefs about medications. Higher scores indicates stronger beliefs about the components of the scale
Change in Attitude towards Medication Questionnaire (AMSQ) score
The AMSQ comprises 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Higher scores on each subscale represent more negative attitudes toward mood stabilizers.
Change in Self-efficacy for Medication Taking Behavior (MASES-R)
The MASES-R measures adherence self-efficacy. Higher scores indicate a greater level of self-efficacy.
Change in Self-Report Habit Index (SRHI)
The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits.

Full Information

First Posted
October 6, 2020
Last Updated
October 6, 2023
Sponsor
Case Western Reserve University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04675593
Brief Title
Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder
Acronym
iTAB-CV RCT
Official Title
Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs. Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD. This practical, technology-facilitated intervention has potential to improve adherence to antihypertensive medication and reduce SBP among high-risk individuals. The intervention is suitable for primary care or mental health settings and has potential for broad scale-up.
Detailed Description
The proposed 5-year project uses a 2-stage randomized controlled trial (RCT) design (Figure 2) to evaluate a brief, practical adherence intervention (iTAB-CV) delivered via interactive text messaging+ Self-Monitoring (SM) compared to SM alone. 200 individuals with BD and HTN who are < 80% adherent with HTN medicine will be enrolled from mental health and primary care settings and the community. The underlying premise is that improving adherence to antihypertensives in BD is likely to be an efficient path to improving health outcomes in a vulnerable population. Findings on the relationship between habit strength, medication attitudes, mood, and adherence in this project will be generalizable to other populations. The entire observation duration will be 11 months. In stage 1, after consenting and passing screen, participants will receive an automated device (eCAP) to track their use of antihypertensive medication. Participants will use the eCAP for 1 month until completing their baseline assessment. At that time, they will be randomized to either Arm 1 (iTAB-CV + self-monitoring) or Arm 2 (self-monitoring alone). Both interventions will be provided for 2 months with an interim phone/video assessment for adherence. At the end of this 2 month stage, participants will be seen for either a virtual or in-person assessment. In stage 2, following the 3-month assessment, those in iTAB-CV will be re-randomized to receive either a high intensity (starts off with 1 reminder per day and tapers down to 1 reminder per week over the course of 2 months) or low intensity (1 reminder per week) booster + self-monitoring compared to self-monitoring alone. Adherence will be assessed by phone/video at 4 months as an interim measurement and a virtual or in-person assessment will occur at 5 months. In stage 3, investigators will follow participants for another 6 months without intervention with 1 interim phone/video assessment and a final virtual or in-person assessment at 11 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Non-Adherence, Medication, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTAB-CV + Self Monitoring
Arm Type
Experimental
Arm Description
Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating
Arm Title
Self Monitoring
Arm Type
Active Comparator
Arm Description
Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating
Arm Title
iTAB-CV + Self Monitoring - High Intensity Booster
Arm Type
Experimental
Arm Description
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.
Arm Title
iTAB-CV + Self Monitoring - Low Intensity Booster
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iTAB-CV
Intervention Description
Individualized Texting for Adherence Building - Cardiovascular (iTAB-CV): a personalized patient-centered text message-based adherence intervention
Intervention Type
Behavioral
Intervention Name(s)
Self-Monitoring
Intervention Description
The Self-Monitoring (control) group will monitor their medication adherence, take their blood pressure weekly with a home blood pressure monitor provided by the study after being trained by the study staff, and rate their mood weekly in response to a text reminder.
Primary Outcome Measure Information:
Title
Change in the Tablet Routine Questionnaire (TRQ)
Description
The TRQ item is a subject report of the percentage of prescribed medications not taken within the past month.
Time Frame
Baseline and Month 4
Title
Change in systolic blood pressure (SBP)
Description
Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure
Time Frame
Baseline and Month 4
Title
Change in Adherence based on the Electronic Monitoring Device (eCAP)
Description
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
Baseline and Month 4
Secondary Outcome Measure Information:
Title
Change in Montgomery Asberg Rating Scale (MADRS) score
Description
The MADRS measures symptoms of depression. The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time Frame
Month 4 and Month 6
Title
Change in engagement with iTAB intervention
Description
Engagement will evaluated using the percentage of texts messages the subject responds to
Time Frame
Month 4 and Month 6
Title
Change in Beliefs About Medicines Questionnaire (BMQ) score
Description
The BMQ assess beliefs about medications. Higher scores indicates stronger beliefs about the components of the scale
Time Frame
Month 4 and Month 6
Title
Change in Attitude towards Medication Questionnaire (AMSQ) score
Description
The AMSQ comprises 19 items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items), denial of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information about psychiatric medication (1 item). Higher scores on each subscale represent more negative attitudes toward mood stabilizers.
Time Frame
Month 4 and Month 6
Title
Change in Self-efficacy for Medication Taking Behavior (MASES-R)
Description
The MASES-R measures adherence self-efficacy. Higher scores indicate a greater level of self-efficacy.
Time Frame
Month 4 and Month 6
Title
Change in Self-Report Habit Index (SRHI)
Description
The SRHI is a measure of habit strength. The minimum score is 12 and the maximum score is 84. A higher score implies stronger habits.
Time Frame
Month 9 and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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? 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Levin, PhD
Phone
216-844-5057
Email
jennifer.levin@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Levin, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
888-819-0004
Email
Bpstudy@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer Levin, PhD
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35768875
Citation
Levin JB, Moore DJ, Depp C, Montoya JL, Briggs F, Rahman M, Stange KC, Einstadter D, Weise C, Conroy C, Yala J, Radatz E, Sajatovic M. Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder (iTAB-CV): study protocol for a 2-stage randomized clinical trial. Trials. 2022 Jun 29;23(1):539. doi: 10.1186/s13063-022-06449-9.
Results Reference
derived

Learn more about this trial

Using mHealth to Improve Adherence and Reduce Blood Pressure in Individuals With Hypertension and Bipolar Disorder

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