Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
Primary Purpose
Diabetes Mellitus, Type 2, Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Medication Adherence
Dietary Modification
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, hypertension, self-management
Eligibility Criteria
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.
Sites / Locations
- Clark K. Sleeth Family Medicine CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
DHSMP core
DHSMP core plus
DHSMP control
Arm Description
Dietary Modification and Physical Activity
Dietary Modification, physical activity and medication adherence
enhanced usual care-3 hours of education plus materials.
Outcomes
Primary Outcome Measures
Clinical outcomes-BP
Difference in BP between baseline and end of program
Clinical Outcomes-A1c
Difference in A1c between baseline and end of program
Secondary Outcome Measures
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.
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.
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.
Behavioral outcome - Activity log; Step count, using pedometer
All participants will be asked to wear a pedometer to record their daily step count.
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.
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.
Full Information
NCT ID
NCT04784130
First Posted
July 29, 2020
Last Updated
December 1, 2022
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT04784130
Brief Title
Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
Official Title
Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension
Keywords
diabetes, hypertension, self-management
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DHSMP core
Arm Type
Experimental
Arm Description
Dietary Modification and Physical Activity
Arm Title
DHSMP core plus
Arm Type
Experimental
Arm Description
Dietary Modification, physical activity and medication adherence
Arm Title
DHSMP control
Arm Type
Active Comparator
Arm Description
enhanced usual care-3 hours of education plus materials.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication Adherence
Intervention Description
Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).
Intervention Type
Behavioral
Intervention Name(s)
Dietary Modification
Intervention Description
Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.
Primary Outcome Measure Information:
Title
Clinical outcomes-BP
Description
Difference in BP between baseline and end of program
Time Frame
6 months after enrollment
Title
Clinical Outcomes-A1c
Description
Difference in A1c between baseline and end of program
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Behavioral outcome - dietary modification for high fat foods; question
Description
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.
Time Frame
6 months after enrollment
Title
Behavioral outcome - healthy eating plan; questions
Description
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.
Time Frame
6 months after enrollment
Title
Behavioral outcome - dietary modification for fruits and vegetables; questions
Description
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.
Time Frame
6 months after enrollment
Title
Behavioral outcome - Activity log; Step count, using pedometer
Description
All participants will be asked to wear a pedometer to record their daily step count.
Time Frame
6 months after enrollment
Title
Behavioral outcome - exercise; questions
Description
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.
Time Frame
6 months after enrollment
Title
Behavioral outcome - medication adherence; questions
Description
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.
Time Frame
6 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ranjita Misra, PhD
Phone
3042934168
Email
ramisra@hsc.wvu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana King, MD
Phone
304-598-6920
Email
kingdana@wvumedicine.org
Facility Information:
Facility Name
Clark K. Sleeth Family Medicine Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501-9190
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ranjita Misra, PhD
Phone
304-293-4168
Email
ramisra@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Dana King, MD
Phone
304-598-6920
Email
kingdana@wvumedicine.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
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