- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03463629
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults With Uncontrolled Type 2 Diabetes
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- The University of Texas Health Science Center at Houston
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Have physician-diagnosed type 2 diabetes
- Be self-identified as Hispanic or Latino
- An A1c value between 9-14% within the last three months
- English or Spanish speaking
Exclusion Criteria:
- Type 1 diabetes or gestational diabetes
- Cognitive impairment
- Prisoners or individuals under detention
- Unable to speak or understand English or Spanish
- Medical history of the end-stage renal disease or undergoing dialysis.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Specialized multidisciplinary diabetes team (SMDT) approach
The implementation of the pilot study will consist of a specialized multidisciplinary diabetes team care (SMDT) that includes endocrinologists, a nurse practitioner, dieticians, pharmacists and a licensed professional counselors (LPCs) to collaborate and coordinate care. Subjects in the pilot study will follow a multidisciplinary team approach process with the following team members: pharmacist, LPC, and dietician. There will be 3 individualized visits: 1 visit with the counselor (LPC), 1 visit with the Pharmacist, and 1 visit with the Dietician. In addition, a follow up phone call post visit, that can range from 5 to 30 minutes, will be scheduled from each of the team members during the study. Also, throughout the pilot study participant's blood glucose readings will be monitored weekly via a transmittable wireless patient transmission monitor. |
The implementation of the pilot study will consist of a specialized multidisciplinary diabetes team care (SMDT) that includes endocrinologists, a nurse practitioner, dieticians, pharmacists and a licensed professional counselors (LPCs) to collaborate and coordinate care. Subjects in the pilot study will follow a multidisciplinary team approach process with the following team members: pharmacist, LPC, and dietician. There will be 3 individualized visits: 1 visit with the counselor (LPC), 1 visit with the Pharmacist, and 1 visit with the Dietician. In addition, a follow up phone call post visit, that can range from 5 to 30 minutes, will be scheduled from each of the team members during the study. Also, throughout the pilot study participant's blood glucose readings will be monitored weekly via a transmittable wireless patient transmission monitor. |
|
Aktiv komparator: Traditional model of care
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services.
Data for this arm will be collected through retrospective chart review.
|
Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in glucose level as indicated by HbA1c levels
Tidsram: baseline, 3 months
|
In this outcome, only the specialized multidisciplinary diabetes team (SMDT) arm (and not the traditional model of care arm) will be assessed.
|
baseline, 3 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in patient satisfaction with a multidisciplinary team approach management as indicated by a diabetes treatment satisfaction questionnaire (DTSQ)
Tidsram: baseline, 3 months
|
baseline, 3 months
|
|
Level of diabetes problem areas as assessed by the Problem Areas in Diabetes Questionnaire (PAID) questionnaire
Tidsram: baseline, 3 months
|
baseline, 3 months
|
|
Change in body mass index (BMI)
Tidsram: baseline, 3 months
|
baseline, 3 months
|
|
Change in weight
Tidsram: baseline, 3 months
|
baseline, 3 months
|
|
Change in blood pressure
Tidsram: baseline, 3 months
|
baseline, 3 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Glucose level as indicated by HbA1c levels
Tidsram: 3 months
|
The objective of this outcome is to compare and evaluate HbA1c results from participants that received care through a multidisciplinary diabetes team with patients that have received only the traditional model of care.
|
3 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Mayra J Cantu, The University of Texas Health Science Center, Houston
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSC-SN-18-0075
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