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No-Show PatientsNCT06501456

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

An observational study of No-Show Patients and Therapeutic Adherence and Compliance, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
46 participants
Where
1 siteArgentina
Study dates
1 Jul 2020to 1 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults with diagnosis of type 2 diabetes mellitus

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Italiano de Buenos Aires

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

Other trials in Argentina

About this study

Official title: Evaluation of the Relationship Between Non-attendance to Appointments and Adherence to Medical Indications, in Adult Patients, With Type 2 Diabetes Mellitus, During the COVID-19 Pandemic: Cross-sectional Studio.

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.

Read the 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.

Keywords
No Show Patients, Patient Compliance, Type 2 diabetes mellitus, COVID-19
Medical subject headings
No-Show Patients, Treatment Adherence and Compliance, Diabetes Mellitus, Type 2, COVID-19, Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2020 - 2021

Secondary outcomes (1)

  1. 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

    Measured: July 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start1 Jul 2020
  3. Primary completion1 Aug 2020
  4. Study completion1 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Retrospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501456
Sponsor's protocol ID
5595
Status last verified
Jul 2024
First submitted
27 May 2021
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32190048

  • 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.

    PubMed 31968127

  • 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.

    PubMed 31862748

  • 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.

    PubMed 33674280

  • 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.

    PubMed 31187148

  • 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.

    PubMed 35832786

  • 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.

    PubMed 24235820

  • 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.

    PubMed 32648278

  • 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.

    PubMed 31062463

Questions about this trial

What is this clinical trial studying?

An observational study of No-Show Patients and Therapeutic Adherence and Compliance, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between non-attendance to scheduled outpatient shifts and adherence to doctor's instructions in adult patients (time frame: 2020 - 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06501456, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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