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

NCT02177656 | Completed

• 1 other identifier: MITI-HF_EGKMF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; self-care; self-care maintenance; self-care management; self-efficacy; quality of life; symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Quality of life

  baseline and 90 days

• Somatic symptom awareness

  baseline and 90 days

• Hospitalizations

  baseline and 90 days

Study Arms (2)

Usual care

NO INTERVENTION

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.

MI tailored intervention

EXPERIMENTAL

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

Interventions

Motivational Interviewing tailored intervention BEHAVIORAL

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.

MI tailored intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included, participants had to be:
• hospitalized with a primary or secondary diagnosis of heart failure
• able to read and speak English
• years of age or older
• living in a setting where they can independently engage in self-care
• living within 30 miles from the University hospital
• have at least adequate health literacy
• symptomatic HF (NYHA II-IV)
• willing to participate

You may not qualify if:

• being on a Milrinone drip
• being on a list for an implanted ventricular assist device or heart transplant
• pregnancy
• psychosis
• cognitive impairment with the inability to participate in the intervention or complete the study instruments
• inability to provide informed consent
• Study enrollment took place from January 2012 to December 2013.

Sponsors & Collaborators

• Ruth Masterson-Creber: lead
• Edna G Kynett Memorial Foundation: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ruth M Masterson Creber, MSc RN PhD (c)

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Barbara Riegel, DNSc, RN

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pre-doctoral student in Nursing Science at the University of Pennsylvania

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 27, 2014
• Study Start: January 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 27, 2014

Record last verified: 2014-06

Locations

US (1)