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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Ecological Nurse Case Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertension diagnosis Attend Bread of Healing Clinic Exclusion Criteria: No Hypertension diagnosis Do not Attend Bread of Healing Clinic

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecological Nurse Case Managemnt<br>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<br>* 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.<br>|
| No Intervention: Comparison<br>Usual Clinical Care - is the usual primary care services delivered at the site of the study, a free clinic. | |

What is the study measuring?
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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 |