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

NCT02457871 | Completed DMC

• 1 other identifier: 144-PRJ94IR
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Automated Community Health Information System (ACHIS) data elements

  6 months

Study Arms (2)

Ecological Nurse Case Managemnt

EXPERIMENTAL

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

Comparison

NO INTERVENTION

Usual Clinical Care - is the usual primary care services delivered at the site of the study, a free clinic.

Interventions

Ecological Nurse Case Management BEHAVIORAL

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.

Ecological Nurse Case Managemnt

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension diagnosis Attend Bread of Healing Clinic

You may not qualify if:

• No Hypertension diagnosis Do not Attend Bread of Healing Clinic

Sponsors & Collaborators

• Bev Zabler: lead
• Medical College of Wisconsin: collaborator

Study Sites (1)

University of Wisconsin Milwaukee College of Nursing

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rachel Schiffman, Ph.D.

  University of Wisconsin-Milwaukee College of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: May 29, 2015
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)