Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT02177656
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2014-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing Tailored Intervention for Patients With Heart Failure (MITI-HF)
Sponsor:
Ruth Masterson-Creber
Organization:
Study Overview
Official Title:
Motivational Interviewing Tailored Intervention for Patients With Heart Failure (MITI-HF)
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITI-HF
Brief Summary:
This study will test the effectiveness of motivational interviewing and skill building compared to usual care to improve self-care in heart failure (HF) patients. The target population is HF patients recruited from the Hospital of the University of Pennsylvania after an in-patient admission. Patients in the intervention arms will receive one home-visit from a nurse who does a self-care intervention followed up by 3 follow-up phone calls.
Detailed Description:
MITI-HF is a prospective, single blinded, pilot randomized single-site trial. The target sample size was 65 participants; however, to account for an estimated 35% attrition rate, the target number for recruitment was 100 participants. We calculated the target sample size based on a 2:1 randomization (intervention: control) with 90% power (5% alpha) to detect a difference of 80% versus 50% (intervention and control group) of scoring over 70, which is the cut-off for adequate self-care at three months between the two groups. The power analysis was performed using G\*Power and confirmed with PASS. Randomization to the intervention or usual care group occurred after the informed consent form was signed and New York Heart Association (NYHA) Functional Class was scored. To achieve balance in both arms of the study, the Minim randomization program was used to minimize prognostic factor differences between groups. Minim stratified participants based on NYHA class and gender to one of two arms in a 2:1 ratio (intervention: control). The research assistants were blinded to group assignment until all study data was collected. All eligible patients were screened for health literacy using a three-question health literacy questionnaire, cognitive impairment using a six-item screener derived from the Mini Mental Status Exam (MMSE), baseline self-care using the SCHFI (v.6.2), and NYHA functional class using the Central Assessment of NYHA Functional Class. A single board-certified cardiologist scored all of the NYHA functional class scores. Medical, socio-demographic, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Heart Failure Somatic Perception Scale (HFSPS) data were collected at baseline via phone call by blinded research assistants (RA) approximately two weeks after hospital discharge. Socio-demographics were assessed using a questionnaire that inquires about gender, age, marital/partnership status, ethnicity/race, and employment. Follow-up data were collected at 90 days by the blinded RAs. If the first call was unsuccessful, the RA would try every 3 to 5 days for up to 60 days. If there was no contact with the participant after 60 days from the expected follow-up date, the participant was considered lost to follow-up. During the follow-up phone call, participants completed the SCHFI, KCCQ, HFSPS and self-reported clinical events within the study period. Self-reported clinical events were verified with a review of the electronic medical record to confirm any hospitalizations, emergency room visits, or outpatient heart failure related visits that occurred within the study period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: