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

Impact of an intervention program on nonadherence to drugs in Ulcerative Colitis Patients: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-79dn4k
Enrollment
Unknown
Registered
2020-01-02
Start date
2019-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proctocolitis

Interventions

Intervention program with educational and behavioral measures Intervention Program The program will last 6 months, with each intervention having its frequency as listed below. Participants in the CG
- printed educational booklet (Appendix 8) will be presented presenting basic contents on the RCU and the importance of adherence to the prescribed drug treatment, prepared by the research team based
- will be targeted on the drugs prescribed for RCU and available for dispensing in the FIMAE (Appendix 10) according to the list of clinical protocols [5]. The verbal guidelines will follow the roadma
Behavioural
Other

Sponsors

Universidade do Estado da Bahia
Lead Sponsor
Programa de Pós-Graduação em Ciências Farmacêuticas - PPGFARMA
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Patients classified as adherents.

Design outcomes

Primary

MeasureTime frame
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. 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

MeasureTime frame
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. 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.

Countries

Brazil

Contacts

Public ContactGenoile Oliveira Silva

Programa de Pós-Graduação em Ciências Farmacêuticas - PPGFARMA

milabahia@yahoo.com.br+55-071-999572121

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026