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

Heart Failure Clinical Trial

— MITI-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177656
• Other study ID #: MITI-HF_EGKMF
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: June 25, 2014
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: University of Pennsylvania: School of Nursing
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Ruth Masterson-Creber	Edna G Kynett Memorial Foundation, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Somatic symptom awareness	Somatic Awareness will be measured using the 18-item HF Somatic Perception Scale (HFSAS).	baseline and 90 days	No
Secondary	Hospitalizations	Hospitalizations were self-reported at 90 days and verified with the medical record.	baseline and 90 days	No