Trial Outcomes & Findings for Group Medical Visits in Heart Failure (NCT NCT02481921)
NCT ID: NCT02481921
Last Updated: 2024-07-24
Results Overview
A self-reported scale that reports how good or bad the respondent's health is TODAY, where higher scores mean a better health state. Minimum = 0 "worst health you can imagine"; maximum= 100 "Best health you can imagine'.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
242 participants
Primary outcome timeframe
180 days
Results posted on
2024-07-24
Participant Flow
Participant milestones
| Measure |
MEDIC-HF
Shared Medical Appointments in Heart Failure: or group clinics with 4-10 patients at a time provided by a multidisciplinary team of health care professionals with expertise in nutrition, social work or health psychologist, and pharmacist or nurse practitioner on alternate fashion to provide heart failure care in in addition to and in support of, the patient's regular individual clinic visits.
|
Usual Care
Usual heart failure care through individual clinic visits that includes but not limited to heart failure, nutrition, cardiology, and primary care, among others, available at the hospital
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
125
|
|
Overall Study
COMPLETED
|
98
|
106
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Group Medical Visits in Heart Failure
Baseline characteristics by cohort
| Measure |
MEDIC-HF
n=117 Participants
Shared Medical Appointments in Heart Failure: or group clinics with 4-10 patients at a time provided by a multidisciplinary team of health care professionals with expertise in nutrition, social work or health psychologist, and pharmacist or nurse practitioner on alternate fashion to provide heart failure care in in addition to and in support of, the patient's regular individual clinic visits.
|
Usual Care
n=125 Participants
Usual heart failure care through individual clinic visits that includes but not limited to heart failure, nutrition, cardiology, and primary care, among others, available at the hospital
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
176 Participants
n=27 Participants
|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 8.7 • n=93 Participants
|
68.9 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
69.3 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
229 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
173 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
117 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
242 Participants
n=27 Participants
|
|
Left ventricular ejection fraction (LVEF) by Echocardiogram
LVEF <40%
|
45 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Left ventricular ejection fraction (LVEF) by Echocardiogram
LVEEF >=40%
|
72 Participants
n=93 Participants
|
82 Participants
n=4 Participants
|
154 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: 8 patients in the MEDIC-HF arm and 9 patients in the Usual Care arm died prior to the final survey. Additionally, 11 patients in the MEDC-HF arm and 10 patients in the Usual Care arm were lost to follow-up or did not complete the final survey. 1 usual care patient did not complete the 6 month survey.
A self-reported scale that reports how good or bad the respondent's health is TODAY, where higher scores mean a better health state. Minimum = 0 "worst health you can imagine"; maximum= 100 "Best health you can imagine'.
Outcome measures
| Measure |
MEDIC-HF
n=117 Participants
Group clinic or shared medical appointment of Education \& Intervention in Heart Failure
Group medical visits: Group clinics or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and/or medication management join to manage heart failure in addition to and in support of, the patient's regular individual clinic visits.
|
Usual Care
n=125 Participants
Usual in-person clinic visits in heart failure
|
|---|---|---|
|
EQ Visual Analog Scale (EQVAS)
Baseline
|
64.6 score on a scale
Standard Deviation 18.1
|
66.8 score on a scale
Standard Deviation 21.7
|
|
EQ Visual Analog Scale (EQVAS)
6 months
|
73.8 score on a scale
Standard Deviation 17.1
|
67.0 score on a scale
Standard Deviation 18.7
|
PRIMARY outcome
Timeframe: 180 daysPopulation: 1 patient in the MEDIC-HF arm did not complete KCCQ at baseline. 8 patients in the MEDIC-HF arm and 9 patients in the Usual Care arm died prior to the final survey. Additionally, 11 patients in the MEDIC-HF arm and 10 patients in the Usual Care arm were lost to follow-up or did not complete the final survey. 1 patient in the usual care arm did not complete EQ-VAS but completed KCCQ.
KCCQ is self reported heart failure-specific health status over the prior two weeks, where higher scores mean a perceived better health status. Score ranges from 0-100 where higher score is better.
Outcome measures
| Measure |
MEDIC-HF
n=117 Participants
Group clinic or shared medical appointment of Education \& Intervention in Heart Failure
Group medical visits: Group clinics or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and/or medication management join to manage heart failure in addition to and in support of, the patient's regular individual clinic visits.
|
Usual Care
n=125 Participants
Usual in-person clinic visits in heart failure
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score
Baseline
|
60.4 score on a scale
Standard Deviation 22.7
|
58.7 score on a scale
Standard Deviation 24.5
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score
6 months
|
70.0 score on a scale
Standard Deviation 21.4
|
68.4 score on a scale
Standard Deviation 23.0
|
Adverse Events
MEDIC-HF
Serious events: 57 serious events
Other events: 42 other events
Deaths: 10 deaths
Usual Care
Serious events: 61 serious events
Other events: 55 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
MEDIC-HF
n=117 participants at risk
Multidisciplinary Education \& Intervention Class in Heart Failure
Group medical visits: Or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and medication management join to manage heart failure in addition to and in support of, the patient's regular physician visits.
|
Usual Care
n=125 participants at risk
Usual heart failure care
|
|---|---|---|
|
Cardiac disorders
Any Hospitalizations
|
48.7%
57/117 • Number of events 97 • 6 months from time of randomization
We collected hospitalizations (SAE) and Emergency room visits (AE) through monthly contact of either phone or in-person visits, in addition to chart reviews
|
48.8%
61/125 • Number of events 125 • 6 months from time of randomization
We collected hospitalizations (SAE) and Emergency room visits (AE) through monthly contact of either phone or in-person visits, in addition to chart reviews
|
Other adverse events
| Measure |
MEDIC-HF
n=117 participants at risk
Multidisciplinary Education \& Intervention Class in Heart Failure
Group medical visits: Or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and medication management join to manage heart failure in addition to and in support of, the patient's regular physician visits.
|
Usual Care
n=125 participants at risk
Usual heart failure care
|
|---|---|---|
|
Cardiac disorders
Any Emergency room visits
|
35.9%
42/117 • Number of events 98 • 6 months from time of randomization
We collected hospitalizations (SAE) and Emergency room visits (AE) through monthly contact of either phone or in-person visits, in addition to chart reviews
|
44.0%
55/125 • Number of events 93 • 6 months from time of randomization
We collected hospitalizations (SAE) and Emergency room visits (AE) through monthly contact of either phone or in-person visits, in addition to chart reviews
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place