Clinical trial NCT02457871: Promoting Self-Management in Low Income African Americans Living With Hypertension
Official title: Promoting Self-Management in Low Income African Americans Living With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2015-05-29
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Hypertension diagnosis Attend Bread of Healing Clinic

Exclusion Criteria:

* No Hypertension diagnosis Do not Attend Bread of Healing Clinic

Primary outcomes:
measure: Change measures
timeFrame: @ baseline,one month, three months, six months
Secondary outcomes:
measure: Automated Community Health Information System (ACHIS) data elements
timeFrame: 6 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin Milwaukee College of Nursing
state: Wisconsin
Study officials:
affiliation: University of Wisconsin-Milwaukee College of Nursing
name: Rachel Schiffman, Ph.D.
role: STUDY_DIRECTOR
References: