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

NCT04893928 | Unknown

• 1 other identifier: 446 LMiPeS0/21
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Social Media; Information and communication technologies

Outcome Measures

Primary Outcomes (3)

• IBD-related knowledge level

  IBD-related knowledge will be assessed using the recently validated QUECOMIICAT (Qüestionari Coneixements Malaltia Inflamatòria Intestinal Catalunya) questionnaire, originally developed in Spanish. Compared with the most well-known CCKNOW, it incorporates IBD updated data. The QUECOMIICAT questionnaire has 25 multiple-choice questions with four options and only one correct answer. Final questionnaire score ranges from 0 to 25.

  One year

• 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 and validated to Spanish. Along 13 questions, patients stratify the level of confidence about correctly taking their medications: 1. Not at all confident (1 point); 2. Somewhat confident (2 points); 3. Very confident (3 points). The sum of results will range from 13 to 39 points. A score 39/39 will be interpreted as the optimal self-efficacy for taking the pharmacological treatment, and a score of 13/39, the lowest.

  One year

• Information and communication technologies 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. Survey approaches aspects related to: 1. Frequency of use of ten different ICTs for personal purposes; 2. Frequency of use of ten different ICTs for IBD-related purposes; 3. A free question about other ICTs that the patient uses for IBD-related purposes; 4. Eight specific IBD-related purposes ICTs are used to; 5. Assessment of ICTs for eight IBD-related purposes; 6. Eight Features an IBD-related App must comprehend. The 18 questions from point b and d will be useful for estimating how much do IBD patients use ICTs for IBD purposes. Questions will be scored from 1 (never or completely disagree) to 5 (daily use or completely agree). A final score will be summarized from 18 to 90. A score of 18/90 will mean the lowest frequency of ICTs use for IBD purposes, and 90/90 the highest.

  One year

Interventions

QUECOMIICAT survey OTHER

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).

Self-Efficacy for Appropriate Medication Use Scale OTHER

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.

ICTs preferences and barriers survey OTHER

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.

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

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.

Eligibility Criteria

• Age: 15 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-patients with IBD confirmed diagnosis, to who they are attended at one of the centres participating in this study.

You may qualify if:

• Every patient ≥15 years old;
• Patients attended by a Gastroenterology consultation;
• Patients attended due to an established diagnosis of Crohn's disease, ulcerative colitis, indeterminate colitis or IBD unclassified;
• Patients whose diagnosis should be based on Lennard-Jonnes criteria: clinical, imaging, endoscopic or anatomopathological findings.

You may not qualify if:

• Patients with a recent diagnosis and no more than a 6-months follow-up;
• Patients ongoing hospitalisation due to severe IBD flare;
• Patients with psychiatric diseases, language impairment, those who find it difficult to visualise the survey or any other condition that difficult answering of a self-administered survey;
• Patients who they are sanitary professional will not be considered for disease-related knowledge level evaluation;
• Patients not under pharmacological treatment (as naïve patients) will not be considered for treatment adherence and compliance evaluation

Sponsors & Collaborators

• Hospital Nacional Profesor Alejandro Posadas: lead
• Hospital Nacional Cayetano Heredia: collaborator
• Instituto Ecuatoriano de Enfermedades Digestivas: collaborator

Study Sites (1)

Miguel Angel Puga Tejada

Buenos Aires, 1076, Argentina

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Behavior; Treatment Adherence and Compliance

Interventions

Focus Groups; Growth and Development

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 20, 2021
• Study Start: May 3, 2021
• Primary Completion: November 1, 2021
• Study Completion: April 30, 2022
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)