Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes

Hypertension Clinical Trial

Official title:

Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784130
• Other study ID #: 1908672206
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained Health Coaches.

Description:

West Virginians have one of the highest prevalence of comorbid diabetes and hypertension in the nation that pose an enormous disease and economic burden in this medically underserved state. Self-management of these two commonly found chronic conditions are an essential component of comprehensive disease management. The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week culturally-tailored, multimodal, diabetes and hypertension self-management program with a core (diet and physical activity) versus core plus (diet, physical activity and medication adherence) to an enhanced usual care (EUC) control group. Seventy-five eligible adults with comorbid diabetes and hypertension will be randomized with a 1:1:1 ratio, based on allocation sequence generated by the bio-statistician investigator in the team. The study will examine the extent to which key components (diet, physical activity, and medication adherence) contribute to the differences in clinical outcomes (HbA1c and blood pressure) between three groups using quantitative and qualitative focus groups and the RE-AIM evaluation framework. The longer term effects of the intervention will be evaluated in a subsequent R01 clinical trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• English speaking adults = 18 years of age;

• co-occurring diagnosis of type 2 diabetes and hypertension

• body mass index = 25.0

• willing to be randomized, and complete the intervention and 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:
• Physical Activity
Respondents will complete activity logs (step count, using pedometer) and surveys (two items from the Summary of Diabetes Self-care activities measure) for physical activity.
• Medication Adherence
Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).
• Dietary Modification
Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.

Locations

Country	Name	City	State
United States	Clark K. Sleeth Family Medicine Center	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-BP	Difference in BP between baseline and end of program	6 months after enrollment
Primary	Clinical Outcomes-A1c	Difference in A1c between baseline and end of program	6 months after enrollment
Secondary	Behavioral outcome - dietary modification for high fat foods; question	Dietary analysis will be based on consumption of high fat foods (such as red meat or full-fat dairy) at baseline and completion of the Program. All participants will be assessed regarding the number of days they eat high fat foods using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "On how many of the last SEVEN DAYS did you eat high fat foods such as red meat or full-fat dairy products?" 0 1 2 3 4 5 6 7. Changes in mean number of days of eating high fat foods will be assessed at baseline and at the completion of the 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 - dietary modification for fruits and vegetables; questions	Dietary analysis will be based on eating fruits and vegetables at baseline and completion of the Program. All participants will be assessed regarding the number of days they eat five or more servings of fruits and vegetables using a survey question from the Summary of Diabetes Self-care activities measure by Toolbert et al., Diabetes Care, 2000. "On how many of the last SEVEN DAYS did you eat five or more servings of fruits and vegetables?" 0 1 2 3 4 5 6 7. Changes in mean number of days of eating fruits and vegetables will be assessed at baseline and at the completion of the program.	6 months after enrollment
Secondary	Behavioral outcome - Activity log; Step count, using pedometer	All participants will be asked to wear a pedometer to record their daily step count.	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
Secondary	Behavioral outcome - medication adherence; questions	Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8). Changes in medication adherence will be assessed at baseline and completion of the program.	6 months after enrollment