Trial Outcomes & Findings for Veterans Intensive Personalized Treatment in Heart Failure (NCT NCT01404988)
NCT ID: NCT01404988
Last Updated: 2015-05-25
Results Overview
Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the "Days Supply" and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the "Days Supply" is subtracted by the number of days between Actual Refill dates, a time span referred to as the "Days Passed". If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a "Gap". The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
6 months from baseline visit
Results posted on
2015-05-25
Participant Flow
Participant milestones
| Measure |
Comprehensive Behavioral Intervention (BI)
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
|
Behavioral & Environmental Intervention (BEI)
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Group (API) -
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
27
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
3
|
Reasons for withdrawal
| Measure |
Comprehensive Behavioral Intervention (BI)
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
|
Behavioral & Environmental Intervention (BEI)
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Group (API) -
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
Baseline Characteristics
Veterans Intensive Personalized Treatment in Heart Failure
Baseline characteristics by cohort
| Measure |
Comprehensive Behavioral Intervention (BI)
n=33 Participants
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.Behavioral Intervention will be delivered over the phone.
|
Behavioral and Environmental Intervention (BEI)
n=33 Participants
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Intervention (API)
n=33 Participants
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
n=99 Participants
|
67.7 years
n=107 Participants
|
67.6 years
n=206 Participants
|
67.0 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
98 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
White (Non-Hispanic)
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
16 participants
n=206 Participants
|
44 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Black (Non-Hispanic)
|
13 participants
n=99 Participants
|
9 participants
n=107 Participants
|
14 participants
n=206 Participants
|
36 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
1 participants
n=206 Participants
|
13 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=157 Participants
|
|
Marital Status
Married
|
25 participants
n=99 Participants
|
16 participants
n=107 Participants
|
25 participants
n=206 Participants
|
66 participants
n=157 Participants
|
|
Marital Status
Not Married
|
8 participants
n=99 Participants
|
17 participants
n=107 Participants
|
8 participants
n=206 Participants
|
33 participants
n=157 Participants
|
|
Education
High School Graduate or Below
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
2 participants
n=206 Participants
|
9 participants
n=157 Participants
|
|
Education
Some College or Higher
|
30 participants
n=99 Participants
|
29 participants
n=107 Participants
|
31 participants
n=206 Participants
|
90 participants
n=157 Participants
|
|
Employment Status
Employed
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
12 participants
n=157 Participants
|
|
Employment Status
Not Employed
|
31 participants
n=99 Participants
|
28 participants
n=107 Participants
|
28 participants
n=206 Participants
|
87 participants
n=157 Participants
|
|
Campus
Manhattan
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
13 participants
n=206 Participants
|
39 participants
n=157 Participants
|
|
Campus
Brooklyn
|
19 participants
n=99 Participants
|
21 participants
n=107 Participants
|
20 participants
n=206 Participants
|
60 participants
n=157 Participants
|
|
Ischemic Heart Disease (IHD)
History of IHD
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Ischemic Heart Disease (IHD)
No History of IHD
|
33 participants
n=99 Participants
|
32 participants
n=107 Participants
|
32 participants
n=206 Participants
|
97 participants
n=157 Participants
|
|
Medication Adherence
Low adherence
|
5 participants
n=99 Participants
|
9 participants
n=107 Participants
|
4 participants
n=206 Participants
|
18 participants
n=157 Participants
|
|
Medication Adherence
Medium Adherence
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
45 participants
n=157 Participants
|
|
Medication Adherence
High Adherence
|
13 participants
n=99 Participants
|
9 participants
n=107 Participants
|
14 participants
n=206 Participants
|
36 participants
n=157 Participants
|
|
Number of Heart Failure Medications
|
3.0 number of heart failure medications
n=99 Participants
|
3.0 number of heart failure medications
n=107 Participants
|
3.0 number of heart failure medications
n=206 Participants
|
3.0 number of heart failure medications
n=157 Participants
|
|
Prescribed ACE inhibitors or Angiotensin II Receptor Blockers (ABRs)
Prescribed ACE and/or ARB
|
23 participants
n=99 Participants
|
25 participants
n=107 Participants
|
31 participants
n=206 Participants
|
79 participants
n=157 Participants
|
|
Prescribed ACE inhibitors or Angiotensin II Receptor Blockers (ABRs)
Not prescribed ACE and/or ARB
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
2 participants
n=206 Participants
|
20 participants
n=157 Participants
|
|
Prescribed Beta Blockers
Prescribed Beta Blockers
|
32 participants
n=99 Participants
|
31 participants
n=107 Participants
|
28 participants
n=206 Participants
|
91 participants
n=157 Participants
|
|
Prescribed Beta Blockers
Not prescribed Beta Blockers
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
8 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 6 months from baseline visitRefill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the "Days Supply" and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the "Days Supply" is subtracted by the number of days between Actual Refill dates, a time span referred to as the "Days Passed". If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a "Gap". The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time.
Outcome measures
| Measure |
Comprehensive Behavioral Intervention (BI) -
n=30 Participants
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Behavioral Intervention will be delivered over the phone.
|
Behavioral & Environmental Intervention (BEI)
n=29 Participants
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Group (API)
n=29 Participants
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Medication Adherence (Refill Compliance for All HF Medications)
|
0.94 proportion of refill compliance
Interval 0.86 to 0.99
|
0.97 proportion of refill compliance
Interval 0.82 to 1.0
|
0.99 proportion of refill compliance
Interval 0.89 to 1.0
|
SECONDARY outcome
Timeframe: 6 months after baselineRefill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the "Days Supply" and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the "Days Supply" is subtracted by the number of days between Actual Refill dates, a time span referred to as the "Days Passed". If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a "Gap". The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time.
Outcome measures
| Measure |
Comprehensive Behavioral Intervention (BI) -
n=24 Participants
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Behavioral Intervention will be delivered over the phone.
|
Behavioral & Environmental Intervention (BEI)
n=20 Participants
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Group (API)
n=25 Participants
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Adherence to ACE Inhibitors and ARB
|
0.98 proportion of refill compliance
Interval 0.82 to 1.0
|
1.0 proportion of refill compliance
Interval 0.88 to 1.0
|
1.0 proportion of refill compliance
Interval 0.99 to 1.0
|
SECONDARY outcome
Timeframe: 6 months from baselineRefill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the "Days Supply" and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the "Days Supply" is subtracted by the number of days between Actual Refill dates, a time span referred to as the "Days Passed". If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a "Gap". The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time.
Outcome measures
| Measure |
Comprehensive Behavioral Intervention (BI) -
n=28 Participants
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Behavioral Intervention will be delivered over the phone.
|
Behavioral & Environmental Intervention (BEI)
n=22 Participants
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Group (API)
n=24 Participants
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Adherence to Beta Blockers
|
0.95 proportion of refill compliance
Interval 0.83 to 1.0
|
0.97 proportion of refill compliance
Interval 0.76 to 1.0
|
1.0 proportion of refill compliance
Interval 0.99 to 1.0
|
SECONDARY outcome
Timeframe: 6 months from baselineAssessed using Morisky medication-taking scale. Higher score corresponds to worse adherence.
Outcome measures
| Measure |
Comprehensive Behavioral Intervention (BI) -
n=27 Participants
Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Behavioral Intervention will be delivered over the phone.
|
Behavioral & Environmental Intervention (BEI)
n=29 Participants
Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
|
Attention Placebo Group (API)
n=30 Participants
Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Self-reported Medication Adherence
High adherence
|
16 participants
|
14 participants
|
21 participants
|
|
Self-reported Medication Adherence
Low adherence
|
2 participants
|
4 participants
|
1 participants
|
|
Self-reported Medication Adherence
Medium adherence
|
9 participants
|
11 participants
|
8 participants
|
Adverse Events
Arm 1
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=33 participants at risk
Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone.
|
Arm 2
n=33 participants at risk
Behavioral \& Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.
Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone
|
Arm 3
n=33 participants at risk
Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.
Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
General disorders
Death
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
General disorders
Cancer
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
0.00%
0/33
|
|
Cardiac disorders
Myocardial infarction
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
Hospital admission for heart failure
|
3.0%
1/33 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
Other adverse events
| Measure |
Arm 1
n=33 participants at risk
Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.
Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone.
|
Arm 2
n=33 participants at risk
Behavioral \& Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.
Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone
|
Arm 3
n=33 participants at risk
Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.
Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone
|
|---|---|---|---|
|
Surgical and medical procedures
coronary artery bypass graft
|
0.00%
0/33
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Cardiac disorders
angina
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Injury, poisoning and procedural complications
Broken bones
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
3.0%
1/33 • Number of events 1
|
|
Injury, poisoning and procedural complications
Torn ligament
|
6.1%
2/33 • Number of events 2
|
0.00%
0/33
|
0.00%
0/33
|
Additional Information
Sundar Natarajan, MD, M.Sc.
VA New York Harbor Healthcare System
Phone: 212-951-3395
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place