Diabetes Mellitus, Type 2NCT04784130
Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
A study testing Physical Activity, Medication Adherence and Dietary Modification in people with Diabetes Mellitus, Type 2 and Hypertension, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Physical Activity, Medication Adherence and Dietary Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clark K. Sleeth Family Medicine Center
Morgantown, West Virginia, 26501-9190
About this study
Official title: Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Physical Activity, Medication Adherence, Dietary Modification
- Keywords
- diabetes, hypertension, self-management
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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 AdherenceBehavioural
Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).
Dietary ModificationBehavioural
Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.
| Study group | Role | What they receive |
|---|---|---|
| DHSMP core | Experimental | Dietary Modification and Physical Activity Receives: Behavioral: Physical Activity; Behavioral: Dietary Modification |
| DHSMP core plus | Experimental | Dietary Modification, physical activity and medication adherence Receives: Behavioral: Physical Activity; Behavioral: Medication Adherence; Behavioral: Dietary Modification |
| DHSMP control | Active comparator | enhanced usual care-3 hours of education plus materials. Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes-BP
Difference in BP between baseline and end of program
Measured: 6 months after enrollment
Clinical Outcomes-A1c
Difference in A1c between baseline and end of program
Measured: 6 months after enrollment
Secondary outcomes (6)
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.
Measured: 6 months after enrollment
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.
Measured: 6 months after enrollment
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.
Measured: 6 months after enrollment
Behavioral outcome - Activity log; Step count, using pedometer
All participants will be asked to wear a pedometer to record their daily step count.
Measured: 6 months after enrollment
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.
Measured: 6 months after enrollment
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.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Oct 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranjita Misra, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784130
- Sponsor's protocol ID
- 1908672206
- Status last verified
- Jan 2024
- First submitted
- 29 Jul 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Diabetes and Hypertension Self-Management for Rural Appalachian Patients In Patient-Centered Medical Homes
- ClinicalTrials.gov ID
- NCT04784130
- Acronym / sponsor ID
- 1908672206
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- diabetes, hypertension, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| DHSMP core | Experimental | Behavioral: Physical Activity, Behavioral: Dietary ModificationDietary Modification and Physical Activity |
| DHSMP core plus | Experimental | Behavioral: Physical Activity, Behavioral: Medication Adherence, Behavioral: Dietary ModificationDietary Modification, physical activity and medication adherence |
| DHSMP control | Active comparator | Behavioral: Physical Activityenhanced usual care-3 hours of education plus materials. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityRespondents will complete activity logs (step count, using pedometer) and surveys (two items from the Summary of Diabetes Self-care activities measure) for physical activity. | Behavioural | DHSMP control, DHSMP core, DHSMP core plus |
| Medication AdherenceRespondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8). | Behavioural | DHSMP core plus |
| Dietary ModificationRespondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake. | Behavioural | DHSMP core, DHSMP core plus |
Primary outcome
Clinical outcomes-BP
Time frame: 6 months after enrollment
Difference in BP between baseline and end of program
Clinical Outcomes-A1c
Time frame: 6 months after enrollment
Difference in A1c between baseline and end of program
6 secondary outcomes
Behavioral outcome - dietary modification for high fat foods; question
Time frame: 6 months after enrollment
Behavioral outcome - healthy eating plan; questions
Time frame: 6 months after enrollment
Behavioral outcome - dietary modification for fruits and vegetables; questions
Time frame: 6 months after enrollment
Behavioral outcome - Activity log; Step count, using pedometer
Time frame: 6 months after enrollment
Behavioral outcome - exercise; questions
Time frame: 6 months after enrollment
Behavioral outcome - medication adherence; questions
Time frame: 6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity, Medication Adherence and Dietary Modification in people with Diabetes Mellitus, Type 2 and Hypertension, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes-BP (time frame: 6 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.