Clinical trial NCT02177656: Motivational Interviewing Tailored Intervention for Patients With Heart Failure (MITI-HF)
Official title: Motivational Interviewing Tailored Intervention for Patients With Heart Failure (MITI-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
self-care
self-care maintenance
self-care management
self-efficacy
quality of life
symptoms
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Edna G Kynett Memorial Foundation
name: University of Pennsylvania
First posted: 2014-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

To be included, participants had to be:

1. hospitalized with a primary or secondary diagnosis of heart failure
2. able to read and speak English
3. 18 years of age or older
4. living in a setting where they can independently engage in self-care
5. living within 30 miles from the University hospital
6. have at least adequate health literacy
7. symptomatic HF (NYHA II-IV)
8. willing to participate

Exclusion Criteria:

Exclusion criteria included:

1. being on a Milrinone drip
2. being on a list for an implanted ventricular assist device or heart transplant
3. pregnancy
4. psychosis
5. cognitive impairment with the inability to participate in the intervention or complete the study instruments
6. inability to provide informed consent

Study enrollment took place from January 2012 to December 2013.

Primary outcomes:
measure: self-care maintenance
timeFrame: baseline, 90 days
measure: self-care management
timeFrame: baseline, 90 days
measure: self-care confidence
timeFrame: baseline, 90 days
Secondary outcomes:
measure: Quality of life
timeFrame: baseline and 90 days
measure: Somatic symptom awareness
timeFrame: baseline and 90 days
measure: Hospitalizations
timeFrame: baseline and 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ruth M Masterson Creber, MSc RN PhD (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Barbara Riegel, DNSc, RN
role: PRINCIPAL_INVESTIGATOR
References: