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Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)

28 september 2026 uppdaterad av: NYU Langone Health

The purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health worker (CHW) led coaching intervention for hypertension control among South Asian patients with co-morbid Diabetes Mellitus type II (DMII) and hypertension. The primary aims are to test the effectiveness of a CHW-led telehealth intervention compared to usual care, and using Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

450

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University
    • New York
      • New York, New York, Förenta staterna, 10016
        • NYU Langone Health

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • identified as of South Asian ethnicity
  • at least 21 years of age
  • a diagnosis of diabetes
  • a diagnosis of hypertension
  • an uncontrolled BP reading (>130/80mmHg) in the last 6 months

Exclusion Criteria:

  • Under the age of 21
  • Women who are pregnant at the time of screening
  • Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency, or chemotherapy-induced)
  • Inability to perform unsupervised physical activity
  • Malignancy or life-threatening illness with life expectancy of <5 years
  • Diagnosed cognitive deficits or limited decision-making capacity

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Community Health Workers (CHW) treatment group

There is a 6-month intervention period immediately following recruitment. Participants enrolled in the intervention will complete 5 educational sessions and attend 2 one-on-one virtual meetings.
Beteende: Integrated CHW Intervention

Participants will undergo all 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources. There will be two one-on-one virtual meetings, up to 9 follow-up phone calls to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
Aktiv komparator: Control group

The control participants will complete only the first educational session. The control arm will receive usual care from their primary care physician (PCP) during the first 12 months of data collection. After 12 months they will be invited to attend remaining group sessions.
Beteende: CHW Session 1 Only

Participants will attend only the first group-based health education session on hypertension and diabetes management.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent of participants achieving BP control, defined as <130/80 mmHg
Tidsram: Month 6

The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at six months.
Month 6

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent of participants achieving BP control, defined as <130/80 mmHg
Tidsram: Month 12

The primary outcome will be the proportion of eligible patients at a practice site to achieve BP control (130/80 mmHg) at twelve months.
Month 12
Change from Baseline in hemoglobin A1c (HbA1c) levels at Month 6
Tidsram: Baseline, Month 6

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in HbA1c levels at Month 12
Tidsram: Baseline, Month 12

Change in HbA1c will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Body mass index (BMI) at Month 6
Tidsram: Baseline, Month 6

Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in BMI at Month 12
Tidsram: Baseline, Month 12

Change in BMI will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Systolic blood pressure (SBP) at Month 6
Tidsram: Baseline, Month 6

Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in SBP at Month 12
Tidsram: Baseline, Month 12

Change in SBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12
Change from Baseline in Diastolic blood pressure (DBP) at Month 6
Tidsram: Baseline, Month 6

Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 6
Change from Baseline in DBP at Month 12
Tidsram: Baseline, Month 12

Change in DBP will be measured in participants of CHW intervention versus the control participants. Clinical data will be retrieved from EHR.
Baseline, Month 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

NYU Langone Health

Samarbetspartners

National Institute on Minority Health and Health Disparities (NIMHD)

Utredare

  • Huvudutredare: Nadia Islam, PhD, NYU Langone Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2024

Primärt slutförande (Beräknad)

1 februari 2028

Avslutad studie (Beräknad)

1 februari 2028

Studieregistreringsdatum

Först inskickad

5 augusti 2024

Först inskickad som uppfyllde QC-kriterierna

5 augusti 2024

Första postat (Faktisk)

7 augusti 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 19-01192-2
  • 5R01MD018528-02 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: laura.wyatt@nyulangone.org . The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Tidsram för IPD-delning

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

Kriterier för IPD Sharing Access

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to laura.wyatt@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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