Role of Information and Communication Technologies for Health Support in Inflammatory Bowel Diseases: The DAMASCO Trial

Summary

In Latin America, inadequate treatment adherence and compliance in IBD patients is around 64% in Brazilians, 54.4% in Mexicans and 50.3% in Argentinians. In industrialised countries, it has been described that in IBD patients, features as younger age, low disease-related knowledge or low treatment adherence and compliance are negatively associated with health-related quality of life (HRQoL). The following research pursues to better understand potential factors related to IBD patients' treatment adherence and compliance as well as patients' IBD-related knowledge level in a Latin American population, and their preferences and barriers when interacting with ICTs for clinical purposes; to develop and to validate an IBD MAHS for Spanish-Speaking patients with Crohn's and ulcerative colitis.

Conditions

• Inflammatory Bowel Diseases
• Knowledge, Attitudes, Practice
• Quality of Life
• Treatment Adherence and Compliance

Interventions

OTHER

QUECOMIICAT survey

IBD-related knowledge. It will be assessed using the recently validated QUECOMIICAT (Qüestionari Coneixements Malaltia Inflamatòria Intestinal Catalunya) questionnaire (27) originally developed in Spanish. Compared with the most well-known CCKNOW (Eaden JA et al in 1999)(28), it incorporates IBD updated data (29).

OTHER

Self-Efficacy for Appropriate Medication Use Scale

Treatment adherence and compliance. It will be assessed using the Self-Efficacy for Appropriate Medication Use Scale (SEAMS), a 13-item self-administered scale previously translated into Spanish and validated by Bozada-Gutiérrez K et al on a Mexican population (3). According to 13 situations asked by the items, patients stratify the level of confidence about correctly taking their medications: 1, not at all confident; 2, somewhat confident; 3, very confident. The sum of results ranges from 13 to 39 points, where higher scores indicate optimal self-efficacy for taking the pharmacological treatment.

OTHER

ICTs preferences and barriers survey

Information and communication technologies (ICTs) preferences and barriers. It will be assessed using an ad-hoc inventory designed by the authorship. It has 45 questions mainly answered through a 5-points Likert scale. This inventory was inspired by the surveys used by Mauer M et al on an international population with urticaria (11), and those used by Reich J et al (30) and Chowdhary TS et al (31) on American patients with IBD. Survey approaches aspects related to: * Frequency of use of ten different ICTs for personal purposes; * Frequency of use of ten different ICTs for IBD-related purposes; * A free question about others ICTs that the patient uses for IBD-related purposes; * Eight specific IBD-related purposes ICTs are used to; * Assessment of ICTs for eight IBD-related purposes; * Eight Features an IBD-related App must comprehend.

OTHER

Focus group and IBD mobile App for health support (MAHS) development and validation

In stage II, a qualitative study will be performed using focus group discussion to explore the experiences and perceptions of patients with IBD using ICTs for health support in different contexts. Focus groups will be established following the Krueger and Casey guidelines (32). Collected data will address the development of an IBD MASH. The developed IBD MASH will be validated on a randomised pilot study along stage III. Methodology and ethical aspects of stage II and III will be defined in another proposal, after stage I preliminary findings.

Sponsors & Collaborators

• Hospital Nacional Cayetano Heredia

  collaborator UNKNOWN

• Instituto Ecuatoriano de Enfermedades Digestivas

  collaborator OTHER

• Hospital Nacional Profesor Alejandro Posadas

  lead OTHER

Eligibility

Min Age

15 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-03

Primary Completion

2021-11-01

Completion

2022-04-30

Countries

• Argentina

Study Locations