NCT06501456

Brief Summary

We will conduct a cross-sectional study involving adults with type 2 diabetes mellitus. Our primary objective is to evaluate the association between nonattendance and participants' adherence to both pharmacological and non-pharmacological medical recommendations, as well as COVID-19 prevention measures. Additionally, we will assess the adherence rates to these medical recommendations, COVID-19 prevention protocols, and the recommended health care practices and controls for patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

May 27, 2021

Last Update Submit

July 9, 2024

Conditions

Keywords

No Show PatientsPatient ComplianceType 2 diabetes mellitusCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Association between non-attendance to scheduled outpatient shifts and adherence to doctor's instructions in adult patients

    Measured the association between absenteeism from outpatient visits and adherence to medical indications in adults with type 2 diabetes mellitus.

    2020 - 2021

Secondary Outcomes (1)

  • Adherence of patients with type 2 diabetes mellitus to medical indications during the pandemic

    July 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with diagnosis of type 2 diabetes mellitus

You may qualify if:

  • Adult patients (over 18 years old), affiliated with the medical insurance of the Hospital Italiano de Buenos Aires for at least two years.
  • Patients with a diagnosis of type 2 diabetes mellitus at least 2 years before the date of entry to the study Will be included.

You may not qualify if:

  • Refusal to participate or to the informed consent process.
  • Difficulties with language or comprehension (includes pathologies that alter the understanding of the indications or compliance with them (dementia, encephalopathy, intellectual disability, psychiatric disorders).
  • Recent hospitalization (the month before the phone call).
  • Medical follow-up outside of Hospital Italiano de Buenos Aires.
  • Work as health personnel.
  • Communication failure (wrong phone number or no response to 3 calls on different days and times)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., C1199ABB, Argentina

Location

Related Publications (9)

  • Zeleke Negera G, Charles Epiphanio D. Prevalence and Predictors of Nonadherence to Diet and Physical Activity Recommendations among Type 2 Diabetes Patients in Southwest Ethiopia: A Cross-Sectional Study. Int J Endocrinol. 2020 Feb 28;2020:1512376. doi: 10.1155/2020/1512376. eCollection 2020.

  • Brewster S, Bartholomew J, Holt RIG, Price H. Non-attendance at diabetes outpatient appointments: a systematic review. Diabet Med. 2020 Sep;37(9):1427-1442. doi: 10.1111/dme.14241. Epub 2020 Feb 3.

  • American Diabetes Association. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S48-S65. doi: 10.2337/dc20-S005.

  • Sun CA, Taylor K, Levin S, Renda SM, Han HR. Factors associated with missed appointments by adults with type 2 diabetes mellitus: a systematic review. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001819. doi: 10.1136/bmjdrc-2020-001819.

  • Lee RRS, Samsudin MI, Thirumoorthy T, Low LL, Kwan YH. Factors affecting follow-up non-attendance in patients with Type 2 diabetes mellitus and hypertension: a systematic review. Singapore Med J. 2019 May;60(5):216-223. doi: 10.11622/smedj.2019042.

  • Pourhabibi N, Mohebbi B, Sadeghi R, Shakibazadeh E, Sanjari M, Tol A, Yaseri M. Determinants of Poor Treatment Adherence among Patients with Type 2 Diabetes and Limited Health Literacy: A Scoping Review. J Diabetes Res. 2022 Jul 4;2022:2980250. doi: 10.1155/2022/2980250. eCollection 2022.

  • Giunta D, Briatore A, Baum A, Luna D, Waisman G, de Quiros FG. Factors associated with nonattendance at clinical medicine scheduled outpatient appointments in a university general hospital. Patient Prefer Adherence. 2013 Nov 8;7:1163-70. doi: 10.2147/PPA.S51841. eCollection 2013.

  • Giunta DH, Alonso Serena M, Luna D, Peroni ML, Sanchez Thomas D, Binder F, Blugerman GA, Fuentes N, Elizondo CM, Gonzalez Bernaldo de Quiros F. Association between non-attendance to outpatient clinics and emergency department consultations, hospitalizations and mortality in a Health Maintenance Organization. Int J Health Plann Manage. 2020 Sep;35(5):1140-1156. doi: 10.1002/hpm.3021. Epub 2020 Jul 9.

  • Giunta DH, Alonso Serena M. Nonattendance rates of scheduled outpatient appointments in a university general hospital. Int J Health Plann Manage. 2019 Oct;34(4):1377-1385. doi: 10.1002/hpm.2797. Epub 2019 May 7.

Related Links

MeSH Terms

Conditions

No-Show PatientsTreatment Adherence and ComplianceDiabetes Mellitus, Type 2COVID-19Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareHealth BehaviorBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Javier Nicolás Giunta, MD

    Hospital Italiano de Buenos Aires

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 27, 2021

First Posted

July 15, 2024

Study Start

July 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations