Evaluation of the Relationship Between Missed Appointment... | NCT06501456

Studies
Evaluation of the Relationship Between Missed Appointments and Adherence to Medical Indications

NCT06501456

Sponsor

Hospital Italiano de Buenos Aires

Status

Completed

Last Update Posted

Jul 15, 2024Actual

Enrollment

46Actual

Phase

Not provided

Conditions

No-Show Patients
Therapeutic Adherence and Compliance
Type 2 Diabetes Mellitus
COVID-19

Interventions

Not provided

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Aug 1, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

May 27, 2021

First Submission Date that Met QC Criteria

Jul 9, 2024

First Posted Date

Jul 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2024

Last Update Posted Date

Jul 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diego Hernan Giunta, Principal investigator, Hospital Italiano de Buenos AiresPrincipal Investigator

Lead Sponsor

Hospital Italiano de Buenos AiresOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Non-attendance at outpatient visits and lack of adherence to medical recommendations are prevalent issues that negatively impact the health care system. While tools exist to assess pharmacological adherence, evaluating adherence to non-pharmacological recommendations remains challenging. Some studies suggest using nonattendance as an objective and easily measurable marker of adherence.

The aim of this study is to evaluate the association between nonattendance and adherence to medical recommendations in adults with type 2 diabetes mellitus.

We will conduct a cross-sectional study involving adults with type 2 diabetes mellitus. We will evaluate the association between participants' nonattendance and their 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 recommendations, COVID-19 prevention measures, and the recommended health care practices and controls for patients with type 2 diabetes mellitus.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Adherence of patients with type 2 diabetes mellitus to medical indications during the pandemic	Report the adherence of patients with type 2 diabetes mellitus to medical indications during the pandemic	July 2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with diagnosis of type 2 diabetes mellitus

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Javier Nicolás Giunta, MD	Hospital Italiano de Buenos Aires	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Italiano de Buenos Aires		Ciudad Autónoma de Buenos Aire	Buenos Aires F.D.	C1199ABB	Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32190048	Result	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.
31968127	Result

ID	Term
D000067455	No-Show Patients
D000074822	Treatment Adherence and Compliance
D003924	Diabetes Mellitus, Type 2
D000086382	COVID-19
D010349	Patient Compliance

ID	Term
D010342	Patient Acceptance of Health Care
D015438	Health Behavior
D001519	Behavior
D003920	Diabetes Mellitus