Motivational Interviewing Tailored Intervention for Patients With Heart Failure (MITI-HF) (MITI-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Motivational Interviewing tailored intervention

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Patients in the usual care group received six patient educational materials in the hospital, a baseline and follow-up phone call by blinded research assistants.
Experimental: MI tailored intervention; The MI intervention was provided by a heart failure specialist nurse. The nurse conducted a home-based motivational interviewing intervention followed up by three phone calls over the course of 90 days. The intervention began with a conversation about the participant's self-identified goals. In the home intervention, the nurse focused on self-care areas that the participant identified as high priority. During the home-based intervention, the participant also set specific goals, which the nurse followed up with and reinforced over the follow-up phone calls.	Behavioral: Motivational Interviewing tailored intervention; MI is grounded in client-centered counseling, cognitive-behavioral therapy, and social cognitive therapy. MI integrates the concepts of relationship building from humanistic therapy with active strategies oriented towards stages of change.The main characteristics of motivational interviewing are: expressing empathy, developing discrepancy, rolling with resistance, and supporting self-efficacy. The interviewer maintains a nonjudgmental approach and allows the patient to determine the need for behavioral change, rather than offering unsolicited advice on the need for change. The interviewer only explores ways to implement change once the patient expresses the desire and confidence to change. The goal of MI is to help individuals work through inherent ambivalence present in problematic or unhealthy behaviors and to help them verbally express reasons for or against change using a nonjudgmental, empathetic and encouraging tone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-care maintenance	Self-Care will be self-reported and measured using the Self-Care of Heart Failure Index (SCHFI). Items measuring self-care maintenance address treatment adherence and self-monitoring, while management focuses on decision-making in response to symptoms. Higher scores reflect better self-care maintenance. Each scale is scored separately; the total possible score for each scale is 100.	baseline, 90 days
self-care management	Self-Care management will be self-reported and measured using the Self-Care of Heart Failure Index (SCHFI). Self care management is a patients ability to recognize symptoms when they occur; independent and interdependent self-care treatments implemented by the patient (e.g., take an extra diuretic for shortness of breath) and ability to evaluate the effectiveness of the treatments implemented. Higher scores reflect better self-care. Each scale is scored separately; the total possible score for each scale is 100.	baseline, 90 days
self-care confidence	Self-Care confidence will be self-reported and measured using the Self-Care of Heart Failure Index (SCHFI). The SCHFI captures confidence in the ability to perform self-care.	baseline, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of Life will be measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item questionnaire that quantifies disease-specific physical limitation, symptom frequency, severity, and change over time, overall quality of life, social interference, and self-efficacy and knowledge.	baseline and 90 days
Somatic symptom awareness	Somatic Awareness will be measured using the 18-item HF Somatic Perception Scale (HFSAS).	baseline and 90 days
Hospitalizations	Hospitalizations were self-reported at 90 days and verified with the medical record.	baseline and 90 days

Collaborators and Investigators

• Sponsor: Ruth Masterson-Creber
• Collaborators: University of Pennsylvania; Edna G Kynett Memorial Foundation
• Investigators: Principal Investigator: Ruth M Masterson Creber, MSc RN PhD (c), University of Pennsylvania; Principal Investigator: Barbara Riegel, DNSc, RN, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 25, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; heart failure; symptoms; self-efficacy; self-care; self-care management; self-care maintenance
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MITI-HF_EGKMF