Diabetes and Hypertension Self Management Program

Hypertension Clinical Trial

Official title:

Diabetes and Hypertension Self Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034548
• Other study ID #: 1607202245
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: August 12, 2020

Study information

• Verified date: September 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week diabetes and hypertension self-management program using trained health coaches.

Description:

West Virginia has high prevalence of comorbid diabetes and hypertension. Most diabetes self-management programs are hospital or clinic based and none are tailored to address the unique needs of rural WV adults with comorbid diabetes (T2DM) and hypertension (HTN). There is a critical need for new and creative community-based, culturally appropriate self-management programs in this medically underserved state. This study will use a wait-listed randomized control trial (RCT) design, using evidence-based interventions, to improve patient self-management behaviors and health outcomes (HbA1c and BP). Eligible adults with comorbid T2DM and HTN will be randomized with a 1:1 ratio to the immediate diabetes and hypertension self-management program (DHSMP; n=35) or to 6-month wait-listed control group (N=35), based on an allocation sequence generated by the biostatistician using a randomly varying block randomization method to ensure equal distribution among treatment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• English speaking adults >= 18 years of age;

• co-occurring diagnosis of T2DM and HTN;

• body mass index >= 25.0

• willing to be randomized and complete all assessments.

Exclusion Criteria:

• currently pregnant or breastfeeding;

• diagnosed with a severe mental illness;

• have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet;

• inability to complete the study protocol.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Behavioral:
• diabetes and hypertension self-management
12-weeks of 75 minutes of educational sessions

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes - A1c	The difference in A1c between baseline and end of program.	6 months after enrollment
Primary	Clinical outcomes - BP	The difference in BP between baseline and end of program.	6 months after enrollment
Secondary	Behavioral outcome - healthy eating plan; questions	Dietary analysis will be based on following a healthy eating plan at baseline and completion of the Program. All participants will be assessed regarding the number of days they followed a healthful eating plan using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "How many of the last SEVEN DAYS have you followed a healthful eating plan?" 0 1 2 3 4 5 6 7. Changes in mean number of days followed a healthy eating plan will be assessed at baseline and at the completion of the program.	6 months after enrollment
Secondary	Behavioral outcome - exercise; questions	All participants will be assessed regarding the number of days they exercise using two survey questions from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. The description of the questions are as follow: Q1. "On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity? (please list the total minutes of continuous activity, including walking)" 0 1 2 3 4 5 6 7 & Q2. "On how many of the last SEVEN DAYS did you participate in a specific exercise session (such as swimming, walking, biking) other than what you do around the house or as part of your work?" 0 1 2 3 4 5 6 7). The total exercise score will be calculated by the mean number of days for the two questions). Changes in mean number of days exercised will be assessed at baseline and at the completion of the program.	6 months after enrollment