Diabetes Mellitus, Type 2, Hypertension
Conditions
Brief summary
The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.
Detailed description
EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) seeks to address evidence gaps that prevent practical use of mobile monitoring-enabled telehealth for clinic-refractory chronic diseases, with an initial focus on Persistent Poorly Controlled Diabetes Mellitus (PPDM) and hypertension. Because our population has already proven refractory to usual care, we will conduct an active comparator randomized trial (N=220) of two 12-month interventions: 1) mobile monitoring as a self-management tool (EXTEND); and 2) a nurse-delivered intervention incorporating mobile monitoring, self-management support, and medication management (EXTEND Plus). The medication management is a care team approach where the nurse works with a Pharmacist who has prescribing rights to optimize medications for the patients. This proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events. Aim 1: Compare the effectiveness of the two 12-month EXTEND interventions for PPDM and hypertension. Hypothesis 1a: Compared to EXTEND, EXTEND Plus will improve primary (HbA1c) and secondary outcomes (e.g., blood pressure, weight, self-management measures) at 12 months; Hypothesis 1b: The relative effects of each intervention will be sustained at 24 months; Hypothesis 1c: Subgroup analyses will identify characteristics associated with high responsiveness to each intervention. Aim 2: Guide scaling and dissemination of the EXTEND interventions by: (A) interviewing patients and stakeholders to clarify implementation barriers, facilitators and process requirements; (B) comparing intervention costs against potential reimbursement mechanisms; and (C) understanding the role of climate change and other social drivers of health on diabetes self-management and intervention engagement. Aim 3: Explore the value of combining mobile monitoring and EHR data for predicting patient safety events (hospitalizations, emergency visits) in the EXTEND study cohort over 24 months. Participants will monitor their data using a suite of remote monitoring devices. Data will be analyzed with PACE by our team. If participants are randomized to the telehealth arm, these data will be reviewed by a RN during a telehealth visit to aid in clinical decision making.
Interventions
BEHAVIORALEXTEND Plus
The EXTEND Plus approach builds patient self-management capacity by focusing on knowledge, self-efficacy, and goal setting (using an RN-delivered, module-based approach). All material is at an 8th grade reading level. Module topics include, but are not limited to, use of self-monitoring of blood glucose (SMBG), BP monitoring, developing a diet plan, medication adherence, hypoglycemia and hypotension self-management, and self-managing insulin. In addition, this intervention component addresses diet and activity self-management during each encounter.
BEHAVIORALEXTEND
EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.
Sponsors
National Institute of Nursing Research (NINR)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization will occur following the baseline appointment. We will not blind participants to arm assignment because they will receive information on both arms during consent. In order to assure blinding of staff conducting outcome data collection, randomization will be managed by staff members not involved with outcome assessment.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes * Poor diabetes control as indicated by at least 1 HbA1c greater than or equal to 8.0% with NO HbA1c less than 8.0% over the past 6 months * At least 1 appointment (office visit, appointment, initial consult, telemedicine) at primary clinic site over the past year * hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes * poor hypertension control as indicated by a clinic systolic BP \>140 AND/OR diastolic BP \>90 over past year * use of an Apple iPhone or Android smartphone * can provide informed consent * can read/speak English * can provide informed consent
Exclusion criteria
* dementia, psychosis, or life-limiting illness * acute coronary event in past year * hypoglycemic seizure/coma over the past year * residence in a nursing home * use of an insulin pump * are or plan to become pregnant * unable or unwilling to use necessary technology to participate in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline, 3, 6, 9, 12, 18 and 24 months | Change in blood sugar (glucose) attached to hemoglobin. Validated point-of-care or lab-based test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Baseline, 3, 6, 9, 12, 18 and 24 months | Measurement taken with lab scale, when patient is lightly clothed, shoes off. |
| Change is Diabetes Distress Scale | Baseline, 6, 12, 18 and 24 months | Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS): 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level. |
| Change in Diabetes Self-Management Questionnaire | Baseline, 6, 12, 18 and 24 months | Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ): 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care. |
| Change in blood pressure | Baseline, 3, 6, 9, 12, 18 and 24 months | Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart. |
| Change in medication non-adherence | Baseline, 6, 12, 18 and 24 months | Validated self-report measure using Voils' medication non-adherence measure. |
| Change in diabetes knowledge | Baseline, 6, 12, 18 and 24 months | Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure. |
| Change in hypertension knowledge | Baseline, 6, 12, 18 and 24 months | Hypertension Knowledge Measure (HKM) is an 11-item validated measure. |
| Change in Perceived Competence Scale | Baseline, 6, 12, 18 and 24 months | Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS): 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater self-efficacy. |
Countries
United States
Outcome results
None listed