Clinical trial NCT06501456: Evaluation of the Relationship Between Missed Appointments and Adherence to Medical Indications
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No-Show Patients
Therapeutic Adherence and Compliance
Type 2 Diabetes Mellitus
COVID-19
Keywords: No Show Patients
Patient Compliance
Type 2 diabetes mellitus
COVID-19
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with diagnosis of type 2 diabetes mellitus

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.

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)

Primary outcomes:
measure: Association between non-attendance to scheduled outpatient shifts and adherence to doctor's instructions in adult patients
timeFrame: 2020 - 2021
Secondary outcomes:
measure: Adherence of patients with type 2 diabetes mellitus to medical indications during the pandemic
timeFrame: July 2020
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Caba
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Javier Nicolás Giunta, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.