- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05120544
Uitbreiding van door technologie ondersteunde verpleegsters verleende zorg voor chronische ziekten (EXTEND)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
- Duke University Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: EXTEND
EXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice). |
EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers. |
|
Experimenteel: EXTEND Plus
EXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in HbA1c
Tijdsspanne: 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. |
Baseline, 3, 6, 9, 12, 18 and 24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Systolic Blood Pressure
Tijdsspanne: 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. |
Baseline, 3, 6, 9, 12, 18 and 24 months
|
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Change in Diastolic Blood Pressure
Tijdsspanne: 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. |
Baseline, 3, 6, 9, 12, 18 and 24 months
|
|
Change in Weight
Tijdsspanne: Baseline, 3, 6, 9, 12, 18 and 24 months
|
Measurement taken with lab scale, when patient is lightly clothed, shoes off. |
Baseline, 3, 6, 9, 12, 18 and 24 months
|
|
Change is Diabetes Distress Scale
Tijdsspanne: 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. |
Baseline, 6, 12, 18 and 24 months
|
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Change in Diabetes Self-Management Questionnaire
Tijdsspanne: 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. |
Baseline, 6, 12, 18 and 24 months
|
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Change in Perceived Competence Scale
Tijdsspanne: 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. |
Baseline, 6, 12, 18 and 24 months
|
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Change in Medication Non-adherence
Tijdsspanne: Baseline, 6, 12, 18 and 24 months
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Validated self-report measure using Voils' medication non-adherence measure. Voils
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Baseline, 6, 12, 18 and 24 months
|
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Change in Diabetes Knowledge
Tijdsspanne: Baseline, 6, 12, 18 and 24 months
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Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure. Diabetes Knowledge
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Baseline, 6, 12, 18 and 24 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ryan J Shaw, RN, PhD, Duke University School of Nursing
- Hoofdonderzoeker: Matthew Crowley, MD, Duke University
Publicaties en nuttige links
Algemene publicaties
- Lee D, Yang Q, Crowley MJ, Hatch D, Pennington G, Matters D, Shaw RJ. Chronic Illness Self-Management Latent Profiles in Individuals With Comorbid Type 2 Diabetes and Hypertension. Sci Diabetes Self Manag Care. 2025 Jun;51(3):250-261. doi: 10.1177/26350106251336311. Epub 2025 May 14.
- Crowley MJ, Lewinski AA, Yang Q, Hatch D, Palipana A, Bosworth HB, Kaufman BG, Chatterjee R, Pennington G, Matters D, Lee D, Urlichich D, Miller HN, German J, Sang S, Smith B, Kokosa S, Gregory P, Roberson CL, Canupp H, Shaw RJ. Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care : A Pragmatic, Randomized, Effectiveness-Implementation Trial. Ann Intern Med. 2026 Jul;179(7):968-979. doi: 10.7326/ANNALS-26-00132. Epub 2026 Jun 23.
- Teo KM, Shaw RJ, Alexopoulos AS, Pennington G, Hatch D, Yang Q, Crowley MJ. Comparing the Effects of Diabetes-Specific and Overall Medication Regimen Complexity on Diabetes Distress. Sci Diabetes Self Manag Care. 2026 Apr;52(2):162-173. doi: 10.1177/26350106261422676. Epub 2026 Feb 25.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRO00107722
- 1R01NR019594-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Our data will be made available for use by investigators not associated with the proposed study within 3 years after the primary results have been published. We will prepare a clear and searchable documentation of the database including a data dictionary, and its linkage to the pertinent study protocols and forms so that diverse investigators can make effective use of the data. For investigators interested in prospective collaborations, we will explore other options to provide support.
IPD-tijdsbestek voor delen
Within 3 years of study data publication.
IPD-toegangscriteria voor delen
For all prospective opportunities (e.g., access to datasets, collaborative studies), we will widely advertise them on Duke Websites and at appropriate scientific meetings.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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