Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension (Phase II)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
-
-
New York
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New York, New York, Stati Uniti, 10016
- NYU Langone Health
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
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. |
|
Comparatore attivo: 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. |
Participants will attend only the first group-based health education session on hypertension and diabetes management. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percent of participants achieving BP control, defined as <130/80 mmHg
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percent of participants achieving BP control, defined as <130/80 mmHg
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nadia Islam, PhD, NYU Langone Health
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 19-01192-2
- 5R01MD018528-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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