Controlling Hyperglycemia Among Minority Population (CHAMP)
24. januar 2018 opdateret af: Sinai Health System
Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care.
The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes.
Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care.
Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants.
A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
272
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60608
- Mount Sinai Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 64 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
*Hyperglycemia with A1C ≥9%
Exclusion Criteria:
- Lives greater than 20 miles driving distance from Mount Sinai Hospital
- Pregnant women with gestational diabetes
- Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Unable to understand and give informed consent in either English or Spanish
- Currently or previously participated in a diabetes research study
- Family member currently enrolled in a diabetes research study
- Previously received diabetes care related cell phone text messages
- Unable to receive text messages 3-4 times per week
- Living in a homeless shelter or temporary housing
- Plans to travel outside of the United States for more than 3 months in next year
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Community Health Worker education
During a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program.
At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management.
At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals.
In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed.
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Diabetes self-management education by community health workers
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Eksperimentel: Cell phone text messaging
The participants in the text messaging group will receive weekly text messages through CareMessage.
Each participant will receive 3-4 text messages per week for 6 months.
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Diabetes self-management education through cell phone text messaging
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Ingen indgriben: Control
The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider.
No additional education will be provided by the research team.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in Hemoglobin A1C (CHW vs. Control)
Tidsramme: 6 months
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To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.
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6 months
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Difference in Hemoglobin A1C (Text Message vs. Control)
Tidsramme: 6 months
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To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage change in diabetes knowledge test scores
Tidsramme: 6 months
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Michigan Diabetes and Research Center Knowledge test
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6 months
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Mean change in diabetes self-efficacy scores
Tidsramme: 6 months
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Perceived competence in diabetes scale
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6 months
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Mean change in diabetes distress scores
Tidsramme: 6 months
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Problem areas in diabetes (PAID-5) scale
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6 months
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Mean change in participants' beliefs about using insulin scores
Tidsramme: 6 months
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Insulin treatment appraisal (ITAS) scale
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6 months
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Mean changes in diabetes self-care activities
Tidsramme: 6 months
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Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking
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6 months
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Percentage of participants who visited a physician due to a diabetes related follow-up
Tidsramme: 6 months
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Self- reported
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Faktiske)
1. september 2017
Studieafslutning (Faktiske)
1. september 2017
Datoer for studieregistrering
Først indsendt
3. februar 2016
Først indsendt, der opfyldte QC-kriterier
11. februar 2016
Først opslået (Skøn)
12. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MSH15-46
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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