Trial Outcomes & Findings for Medication Adherence in Hypertensive Individuals With Bipolar Disorder (NCT NCT02983877)
NCT ID: NCT02983877
Last Updated: 2019-12-09
Results Overview
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.
COMPLETED
NA
38 participants
change from Screen (Week 0) to V2 (week 12)
2019-12-09
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
iTAB-CV
n=38 Participants
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.
|
|---|---|
|
Age, Continuous
|
51.53 years
STANDARD_DEVIATION 9.06 • n=38 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=38 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=38 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=38 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
|
Years of education
|
13.18 years
STANDARD_DEVIATION 2.69 • n=38 Participants
|
|
Employment
Full time/homemaker
|
1 Participants
n=38 Participants
|
|
Employment
Part time
|
3 Participants
n=38 Participants
|
|
Employment
Unemployed, but expected to work by self or others
|
6 Participants
n=38 Participants
|
|
Employment
Disabled
|
28 Participants
n=38 Participants
|
|
Bipolar disorder type
Bipolar Disorder Type I
|
28 Participants
n=38 Participants
|
|
Bipolar disorder type
Bipolar Disorder Type II
|
10 Participants
n=38 Participants
|
|
Age of hypertension diagnosis
|
36.95 years
STANDARD_DEVIATION 15.66 • n=38 Participants
|
|
Age of bipolar disorder diagnosis
|
31.95 years
STANDARD_DEVIATION 13.46 • n=38 Participants
|
|
hypertension-related hospitalizations
|
3.16 occurrences
n=19 Participants • 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.
|
|
substance use-related hospitalizations
|
3.00 occurrences
n=12 Participants • 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.
|
|
History of physical abuse
Yes
|
20 Participants
n=38 Participants
|
|
History of physical abuse
No
|
18 Participants
n=38 Participants
|
|
History of sexual abuse
Yes
|
20 Participants
n=38 Participants
|
|
History of sexual abuse
No
|
18 Participants
n=38 Participants
|
|
Mental illness in the family
Yes
|
30 Participants
n=38 Participants
|
|
Mental illness in the family
No
|
8 Participants
n=38 Participants
|
|
Smokes cigarettes
Yes
|
23 Participants
n=38 Participants
|
|
Smokes cigarettes
No
|
15 Participants
n=38 Participants
|
|
Median number of cigarettes smoked per day
|
6.00 cigarettes per day
n=23 Participants • 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.
|
|
BMI
|
22.15 kg/m^2
STANDARD_DEVIATION 9.40 • n=38 Participants
|
PRIMARY outcome
Timeframe: change from Screen (Week 0) to V2 (week 12)Population: Baseline descriptives
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.
Outcome measures
| Measure |
Whole Sample
n=38 Participants
These analyses were run on the entire sample as a whole, N= 38.
|
|---|---|
|
Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)
Screen visit antihypertensive TRQ (past week)
|
42.86 percentage of days with missed doses
Standard Deviation 23.15
|
|
Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)
V2 (week 12) antihypertensive TRQ (past week)
|
21.24 percentage of days with missed doses
Standard Deviation 17.95
|
SECONDARY outcome
Timeframe: change from Screen (Week 0) to V2 (week 12)Outcome measures
| Measure |
Whole Sample
n=38 Participants
These analyses were run on the entire sample as a whole, N= 38.
|
|---|---|
|
Change in Systolic Blood Pressure
Screen visit systolic blood pressure
|
144.81 mmHg
Standard Deviation 15.46
|
|
Change in Systolic Blood Pressure
V2 (12 week) systolic blood pressure
|
136.02 mmHg
Standard Deviation 17.77
|
SECONDARY outcome
Timeframe: change from Screen (Week 0) to V2 (week 12)Population: Missing data for one participants (i.e. n= 37).
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.
Outcome measures
| Measure |
Whole Sample
n=37 Participants
These analyses were run on the entire sample as a whole, N= 38.
|
|---|---|
|
Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)
Screen visit bipolar medication TRQ (past week)
|
43.95 percentage of days with missed doses
Standard Deviation 27.27
|
|
Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)
V2 (12 week) bipolar medication TRQ (past week)
|
25.86 percentage of days with missed doses
Standard Deviation 23.01
|
SECONDARY outcome
Timeframe: change from Baseline (Week 4) to V2 (week 12)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.
Outcome measures
| Measure |
Whole Sample
n=38 Participants
These analyses were run on the entire sample as a whole, N= 38.
|
|---|---|
|
Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)
Baseline visit antihypertensive eCAP (past week)
|
37.70 percentage of medications missed
Standard Deviation 28.19
|
|
Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)
V2 (12 week) antihypertensive eCAP (past week)
|
34.75 percentage of medications missed
Standard Deviation 28.88
|
Adverse Events
iTAB-CV
Serious adverse events
| Measure |
iTAB-CV
n=38 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
stomach pain
|
2.6%
1/38 • Number of events 3 • 3 months
|
|
Social circumstances
Voluntary alcohol rehab at VA
|
2.6%
1/38 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
diverticulitis
|
2.6%
1/38 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
kidney stones
|
2.6%
1/38 • Number of events 2 • 3 months
|
|
Psychiatric disorders
suicidal thoughts
|
5.3%
2/38 • Number of events 2 • 3 months
|
|
Blood and lymphatic system disorders
high blood pressure
|
2.6%
1/38 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
hyperglycemia
|
2.6%
1/38 • Number of events 1 • 3 months
|
|
General disorders
swollen legs
|
2.6%
1/38 • Number of events 2 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place