Promoting Self-Management in Low Income African Americans Living With Hypertension (ENCM)

The specific study aims are to: 1) examine differences between an Ecological Nursing Case Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Ecological Nurse Case Management

Detailed Description

Health outcomes of chronically ill low-income adults are costly in both fiscal and human terms. Although advances have been made in understanding how nurse case management (NCM) can contribute to self-management (SM) behaviors, the factors that contribute to sustained SM behaviors in low-income African American populations are not well understood. This study will examine the impact of Ecological Nurse Case Management (ENCM) on self-management behaviors, health status, and self-efficacy of poor, chronically ill, African American adults. In addition, we will explore moderating effects to determine if the ENCM intervention is differentially effective based on gender or perceived stress. The study will use the UWM Automated Community Health Information System, a relational electronic health record, to document the individualized ECNM intervention and dose of the intervention. The specific study aims are to: 1) examine differences between an ENCM treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention. Acknowledging the small sample size, mixed models for repeated measures data (at baseline and M1, 3, and 6 post-intervention) will be fit to interactions involving moderating variables of gender and stress. The ENCM intervention draws on evidence that given the proper tools (i.e., knowledge, skills and support), individuals can learn to better self-manage their symptoms on a day to day basis and better utilize the health care resources available to them.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • University of Wisconsin Milwaukee College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hypertension diagnosis Attend Bread of Healing Clinic

Exclusion Criteria:

• No Hypertension diagnosis Do not Attend Bread of Healing Clinic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ecological Nurse Case Managemnt; Ecological Nurse Case Management (ENCM) group receives 6 months of ENCM services in addition to their usual primary care services at the study site.	Behavioral: Ecological Nurse Case Management; The Ecological Nurse Case Management (ENCM) intervention allows for individualized case management based on client preferences through mutual goal setting and client choice points, nursing assessments, the nurse's analytic decision-making process and critical thinking, and nursing actions.
No Intervention: Comparison; Usual Clinical Care - is the usual primary care services delivered at the site of the study, a free clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change measures	NIH Toolbox Perceived Stress Survey NIH Toolbox Self-efficacy Survey Hypertension Self-Care Profile Blood pressure, BMI and Waist Circumference changes Hypertension Self-Care Profile	@ baseline,one month, three months, six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Automated Community Health Information System (ACHIS) data elements	Data elements of ACHIS, including Omaha System informatics codes, will be used to measure the intervention dose and intervention outcomes of nurse rated knowledge and client self-reported health status.	6 months

Collaborators and Investigators

• Sponsor: Bev Zabler
• Collaborators: Medical College of Wisconsin
• Investigators: Study Director: Rachel Schiffman, Ph.D., University of Wisconsin-Milwaukee College of Nursing

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 144-PRJ94IR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No