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Trial Outcomes & Findings for Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study (NCT NCT00555360)

NCT ID: NCT00555360

Last Updated: 2015-09-15

Results Overview

Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

372 participants

Primary outcome timeframe

twelve-month followup

Results posted on

2015-09-15

Participant Flow

Participant milestones

Participant milestones
Measure
Standard mHealth
Weekly IVR calls for 12 months
mHealth Plus CarePartner
Wkly IVR calls for 12 months+feedback to CarePartner
Overall Study
STARTED
183
189
Overall Study
COMPLETED
156
153
Overall Study
NOT COMPLETED
27
36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard mHealth
n=156 Participants
Weekly IVR calls for 12 months
mHealth Plus CarePartner
n=153 Participants
Wkly IVR calls for 12 months+feedback to CarePartner
Total
n=309 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
70 Participants
n=5 Participants
74 Participants
n=7 Participants
144 Participants
n=5 Participants
Age, Categorical
>=65 years
86 Participants
n=5 Participants
79 Participants
n=7 Participants
165 Participants
n=5 Participants
Age, Continuous
68.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
67.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
68.1 years
STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
154 Participants
n=5 Participants
153 Participants
n=7 Participants
307 Participants
n=5 Participants
Region of Enrollment
United States
156 participants
n=5 Participants
153 participants
n=7 Participants
309 participants
n=5 Participants
Heart Failure-specific Quality of Life
40.4 units on a scale
STANDARD_DEVIATION 25.1 • n=5 Participants
41.2 units on a scale
STANDARD_DEVIATION 23.7 • n=7 Participants
40.8 units on a scale
STANDARD_DEVIATION 24.4 • n=5 Participants
Revised Heart Failure Self-Care Behavior Scale (HFSCB)
82.9 units on a scale
STANDARD_DEVIATION 19.3 • n=5 Participants
83.1 units on a scale
STANDARD_DEVIATION 16.3 • n=7 Participants
83.0 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
Adherent to Heart Failure Medication
81 participants
n=5 Participants
84 participants
n=7 Participants
165 participants
n=5 Participants

PRIMARY outcome

Timeframe: twelve-month followup

Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.

Outcome measures

Outcome measures
Measure
Standard mHealth
n=156 Participants
Weekly IVR calls for 12 months
mHealth+Carepartner
n=153 Participants
Weekly IVR calls for 12 months+CarePartner feedback
Heart Failure-specific Quality of Life
37.0 units on a scale
Standard Deviation 25.7
38.6 units on a scale
Standard Deviation 24.8

SECONDARY outcome

Timeframe: twelve-month follow-up

Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.

Outcome measures

Outcome measures
Measure
Standard mHealth
n=156 Participants
Weekly IVR calls for 12 months
mHealth+Carepartner
n=153 Participants
Weekly IVR calls for 12 months+CarePartner feedback
Revised Heart Failure Self-Care Behavior Scale (HFSCB)
92.1 units on a scale
Standard Deviation 18.7
90.5 units on a scale
Standard Deviation 17.0

SECONDARY outcome

Timeframe: twelve-month follow-up

Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.

Outcome measures

Outcome measures
Measure
Standard mHealth
n=156 Participants
Weekly IVR calls for 12 months
mHealth+Carepartner
n=153 Participants
Weekly IVR calls for 12 months+CarePartner feedback
Adherent to Heart Failure Medication
52.6 percentage of participants/perfect adher
66.7 percentage of participants/perfect adher

Adverse Events

Standard mHealth

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

mHealth+Carepartner

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Piette, PhD

Ann Arbor VA Healthcare System

Phone: 734-845-3626

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place