Multicomponent provider-patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes : clinical trial protocol for the ACHIEVE study
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Type 2 diabetes (T2D) is one of the most frequent comorbid medical conditions in pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual and infant. Achieving glycaemic control can be challenging for Medicaid-insured pregnant individuals who experience a high burden of unmet social needs. Multifaceted provider-patient-based approaches are needed to improve glycaemic control in this high-risk pregnant population. Mobile health (mHealth) applications (app), provider dashboards, continuous glucose monitoring (CGM) and addressing social needs have been independently associated with improved glycaemic control in non-pregnant individuals living with diabetes. The combined effect of these interventions on glycaemic control among pregnant individuals with T2D remains to be evaluated.
METHODS AND ANALYSIS: In a two-arm randomised controlled trial, we will examine the combined effects of a multicomponent provider-patient intervention, including a patient mHealth app, provider dashboard, CGM, a community health worker to address non-medical health-related social needs and team-based care versus the current standard of diabetes and prenatal care. We will recruit 124 Medicaid-insured pregnant individuals living with T2D, who are ≤20 weeks of gestation with poor glycaemic control measured as a haemoglobin A1c ≥ 6.5% assessed within 12 weeks of trial randomisation or within 12 weeks of enrolling in prenatal care from an integrated diabetes and prenatal care programme at a tertiary care academic health system located in the Midwestern USA. We will measure how many individuals achieve the primary outcome of glycaemic control measured as an A1c<6.5% by the time of delivery, and secondarily, adverse pregnancy outcomes; patient-reported outcomes (eg, health and technology engagement, literacy and comprehension; provider-patient communication; diabetes self-efficacy; distress, knowledge and beliefs; social needs referrals and utilisation; medication adherence) and CGM measures of glycaemic control (in the intervention group).
ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2022H0399; date: 3 June 2023). We plan to submit manuscripts describing the user-designed methods and will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.
TRIAL REGISTRATION NUMBER: NCT05662462.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
BMJ open - 13(2023), 5 vom: 10. Mai, Seite e074657 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Venkatesh, Kartik K [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 12.05.2023 Date Revised 14.05.2023 published: Electronic ClinicalTrials.gov: NCT05662462 Citation Status MEDLINE |
|---|
| doi: |
10.1136/bmjopen-2023-074657 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM35667374X |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM35667374X | ||
| 003 | DE-627 | ||
| 005 | 20231226210341.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/bmjopen-2023-074657 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1188.xml |
| 035 | |a (DE-627)NLM35667374X | ||
| 035 | |a (NLM)37164461 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Venkatesh, Kartik K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Multicomponent provider-patient intervention to improve glycaemic control in Medicaid-insured pregnant individuals with type 2 diabetes |b clinical trial protocol for the ACHIEVE study |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 12.05.2023 | ||
| 500 | |a Date Revised 14.05.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05662462 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Type 2 diabetes (T2D) is one of the most frequent comorbid medical conditions in pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual and infant. Achieving glycaemic control can be challenging for Medicaid-insured pregnant individuals who experience a high burden of unmet social needs. Multifaceted provider-patient-based approaches are needed to improve glycaemic control in this high-risk pregnant population. Mobile health (mHealth) applications (app), provider dashboards, continuous glucose monitoring (CGM) and addressing social needs have been independently associated with improved glycaemic control in non-pregnant individuals living with diabetes. The combined effect of these interventions on glycaemic control among pregnant individuals with T2D remains to be evaluated | ||
| 520 | |a METHODS AND ANALYSIS: In a two-arm randomised controlled trial, we will examine the combined effects of a multicomponent provider-patient intervention, including a patient mHealth app, provider dashboard, CGM, a community health worker to address non-medical health-related social needs and team-based care versus the current standard of diabetes and prenatal care. We will recruit 124 Medicaid-insured pregnant individuals living with T2D, who are ≤20 weeks of gestation with poor glycaemic control measured as a haemoglobin A1c ≥ 6.5% assessed within 12 weeks of trial randomisation or within 12 weeks of enrolling in prenatal care from an integrated diabetes and prenatal care programme at a tertiary care academic health system located in the Midwestern USA. We will measure how many individuals achieve the primary outcome of glycaemic control measured as an A1c<6.5% by the time of delivery, and secondarily, adverse pregnancy outcomes; patient-reported outcomes (eg, health and technology engagement, literacy and comprehension; provider-patient communication; diabetes self-efficacy; distress, knowledge and beliefs; social needs referrals and utilisation; medication adherence) and CGM measures of glycaemic control (in the intervention group) | ||
| 520 | |a ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2022H0399; date: 3 June 2023). We plan to submit manuscripts describing the user-designed methods and will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05662462 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, U.S. Gov't, P.H.S. | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Diabetes in pregnancy | |
| 650 | 4 | |a General diabetes | |
| 650 | 4 | |a Health Equity | |
| 650 | 4 | |a OBSTETRICS | |
| 650 | 7 | |a Glycated Hemoglobin |2 NLM | |
| 650 | 7 | |a Blood Glucose |2 NLM | |
| 700 | 1 | |a Joseph, Joshua J |e verfasserin |4 aut | |
| 700 | 1 | |a Swoboda, Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Strouse, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Hoseus, Jenelle |e verfasserin |4 aut | |
| 700 | 1 | |a Baker, Carrie |e verfasserin |4 aut | |
| 700 | 1 | |a Summerfield, Taryn |e verfasserin |4 aut | |
| 700 | 1 | |a Bartholomew, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Buccilla, Lisa |e verfasserin |4 aut | |
| 700 | 1 | |a Pan, X |e verfasserin |4 aut | |
| 700 | 1 | |a Sieck, Cynthia |e verfasserin |4 aut | |
| 700 | 1 | |a McAlearney, Ann Scheck |e verfasserin |4 aut | |
| 700 | 1 | |a Huerta, Timothy R |e verfasserin |4 aut | |
| 700 | 1 | |a Fareed, Naleef |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMJ open |d 2012 |g 13(2023), 5 vom: 10. Mai, Seite e074657 |w (DE-627)NLM215724372 |x 2044-6055 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2023 |g number:5 |g day:10 |g month:05 |g pages:e074657 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/bmjopen-2023-074657 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2023 |e 5 |b 10 |c 05 |h e074657 | ||