HypertensioniTAB-CVNCT02983877
Medication Adherence in Hypertensive Individuals With Bipolar Disorder
A study testing iTAB-CV in people with Hypertension and Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension, Bipolar Disorder
- What is being tested?
- iTAB-CV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2017to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will have a clinical diagnosis of BD for at least 2 years as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (52)
- Have stage 1 or 2 HTN with a systolic pressure ≥130
- Carry a diagnosis of HTN per patient self-report ≥ 6 months prior to enrollment
- Have been prescribed at least one regularly scheduled antihypertensive medication for ≥ 3 months since diagnosis
- Have self-reported poor adherence to antihypertensive medication defined as at least 20% of days with missed doses for at least one antihypertensive in either the past week or past month as identified by the Tablets Routine Questionnaire (TRQ).
- Be able to participate in psychiatric interviews
Who cannot join
- Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
- Unable or unwilling to give written, informed consent to study participation
- Under the age of 21
- 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 and the Mini-International Neuropsychiatric Interview (MINI). 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 such individuals are deemed stable, they may be once again considered for inclusion in the research.
- Individuals who are monolingual, non-English speaking will be excluded. Given the relatively small sample size in the proposed study, it would not be practical to conduct sub-group analyses. Also, the study assessment tools and the texting intervention are not available in other languages and would be impractical to develop. Based upon our BD adherence work, 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.
- Illiterate participants will be excluded because reading is an essential skill required to complete self-report questionnaires administered during the study as well as to respond to the text messages which make up the intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center and Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Improving Medication Adherence in Hypertensive Individuals With Bipolar Disorder
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.
Read the detailed description
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.
- Conditions
- Hypertension, Bipolar Disorder
- Being tested
- iTAB-CV
- Medical subject headings
- Hypertension, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTAB-CVBehavioural
Also called Individualized Texting for Adherence Building-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: iTAB-CV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from Screen (Week 0) to V2 (week 12)
Secondary outcomes (3)
Change in Systolic Blood Pressure
Measured: 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.
Measured: 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.
Measured: change from Baseline (Week 4) to V2 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start13 Mar 2017
- Primary completion4 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Levin, Case Western Reserve University
- Investigators
- Jennifer Levin, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983877
- Sponsor's protocol ID
- HL132364
- Acronym
- iTAB-CV
- Status last verified
- Dec 2019
- First submitted
- 29 Nov 2016
- Last updated
- 9 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30991908
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence in Hypertensive Individuals With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02983877
- Acronym / sponsor ID
- iTAB-CV / HL132364
- Conditions
- Hypertension, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| iTAB-CV | Experimental | Behavioral: iTAB-CVIn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants will have a clinical diagnosis of BD for at least 2 years as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) (52)
- Have stage 1 or 2 HTN with a systolic pressure ≥130
- Carry a diagnosis of HTN per patient self-report ≥ 6 months prior to enrollment
- Have been prescribed at least one regularly scheduled antihypertensive medication for ≥ 3 months since diagnosis
- Have self-reported poor adherence to antihypertensive medication defined as at least 20% of days with missed doses for at least one antihypertensive in either the past week or past month as identified by the Tablets Routine Questionnaire (TRQ).
Key exclusion criteria (6 listed)
- Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
- Unable or unwilling to give written, informed consent to study participation
- Under the age of 21
- 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 and the Mini-International Neuropsychiatric Interview (MINI). 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 such individuals are deemed stable, they may be once again considered for inclusion in the research.
- Individuals who are monolingual, non-English speaking will be excluded. Given the relatively small sample size in the proposed study, it would not be practical to conduct sub-group analyses. Also, the study assessment tools and the texting intervention are not available in other languages and would be impractical to develop. Based upon our BD adherence work, 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTAB-CVAlso: Individualized Texting for Adherence Building-CVStage 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. | Behavioural | iTAB-CV |
Primary outcome
Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)
Time frame: change from Screen (Week 0) to V2 (week 12)
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.
3 secondary outcomes
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)
Time frame: change from Screen (Week 0) to V2 (week 12)
Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)
Time frame: change from Baseline (Week 4) to V2 (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30991908Levin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Levin, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTAB-CV in people with Hypertension and Bipolar Disorder, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ) (time frame: change from Screen (Week 0) to V2 (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.