Effect of a program on drug use in patients with Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Proctocolitis; Medication Adherence; C06.405.205.265.767; F01.100.150.750.500.600.500

• Registration Number: RBR-79dn4k
• Lead Sponsor: niversidade do Estado da Bahia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients diagnosed with ulcerative colitis (UC); at least 3 months of active registration in the Farmácia Integrada do Medicamento na Atenção Especializada(FIMAE); prescribed with at least 01 medicine to treat UC; of the same age or over 18 years; able to respond to the research tools; agrees to sign the Informed Consent Form (TCLE); assisted by outpatient clinics of Inflammatory Bowel Disease (IBD) at the Hospital Geral Roberto Santos(HGRS) or Hospital Universitário Professor Edgard Santos HUPES); owns a cell phone.

Exclusion Criteria

Patients classified as adherents.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence (incidence) of the primary outcome of the study (non-adherence) will be calculated by the ratio of the total non-adherent participants to the total number of participants in the group, multiplied by 100, calculated separately for the intervention and comparison groups. Non-adherence will be measured using the Morisky-Green-Levine Test. <br>The relative risk (RR) with the respective 95% confidence interval (95% CI) will be used as a measure of effectiveness, obtained by the ratio between the incidence of the intervention group and the incidence of the comparative group.

Secondary Outcome Measures

Name	Time	Method
Quality of life will be compared between the intervention groups and the control group, measured by the global score punctuated by the Brazil SF-36 instrument, before and after the intervention program applied for 6 months. <br>The relative risk (RR) with the respective 95% confidence interval (95% CI) will be used as a measure of effectiveness, obtained by the ratio between the incidence of the intervention group and the incidence of the comparative group.;The clinical status of ulcerative colitis, measured by the Lichtiger Index, will be compared between the intervention and control groups, before and after intervention programme applied during 6 months. The relative risk (RR) with the respective 95% confidence interval (95% CI) will be used as a measure of effectiveness, obtained by the ratio between the incidence of the intervention group and the incidence of the comparative group.