Clinical trial NCT04893928: Role of Information and Communication Technologies for Health Support in Inflammatory Bowel Diseases: The DAMASCO Trial
Official title: Role of Information and Communication Technologies for Health Support in Inflammatory Bowel Diseases: The DAMASCO Trial (Stage I)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Knowledge, Attitudes, Practice
Quality of Life
Treatment Adherence and Compliance
Keywords: Social Media
Information and communication technologies
Lead sponsor: Hospital Nacional Profesor Alejandro Posadas
Sponsor class: OTHER
Collaborators: name: Hospital Nacional Cayetano Heredia
name: Instituto Ecuatoriano de Enfermedades Digestivas
First posted: 2021-05-20
Enrollment: 351
Sex: ALL
Minimum age (years): 15
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: State of the Art:

A chronic condition with a particular approach but also with an unpredictable course difficult treatment adherence and compliance is seen among Inflammatory Bowel Diseases (IBD) patients. 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 the last, a sub-analysis per medication estimated an inadequate adherence in 52.2%, 40.2% and 15.3% for 5-aminosalicylates (5-ASA), thiopurine and biologics, respectively.

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). In Uruguay, IBD annual incidence rate between 2007-2011 was higher in children and young adults (3.45 and 9.12 per 105 habitants) than ≥45 years-old patients (2.92 per 105 habitants). In Chile, using the Crohn's and Colitis Knowledge score (CCKNOW), there were estimated a median score of 9 out of 24 (range 1 - 20). Using the IBD-32 questionnaire in a 50-patients cross-section study, 40% moderate to low HRQoL was identified in Argentina.

Living with chronic diseases is associated with the necessity of self-management education (SME). SME may reduce depression and anxiety, improving HRQoL. As in other chronic diseases, the 90s Internet advent was accompanied by new IBD-related websites, which served mainly as scholarly sources for IBD patients. Since Web 2.0 in the 2000s, social media (including social networks) emergence let users create and share content across digital devices. Web sites, emails, blogs, social media and mobile Applications software (mobile Apps) comprehend Information and communication technologies (ICTs) resources, which facilitates SME through specific disease-related knowledge transfer using the internet.

A United States cross-sectional study demonstrated in 1960 IBD patients that 32% agreed that social media could help disease management. Social media use was higher in IBD younger patients, female, active disease and Crohn's disease. However, 50% could not rate the quality of IBD information posted online, and 68.3% had concerns about privacy or confidentiality. The rising of IBD-related content represented the following limitations: educational content low in quality, non-supervised content by corresponded healthcare providers, and privacy issues.

The popularity of smartphones and tablets has facilitated an increased development of mobile Apps for health support (MAHS) designed by healthcare providers. A good example is the MAHS called myIBDcoach, an HTML web-based tool designed for computers, tablets, and smartphones in the IBD context. Through a randomised trial among Dutch patients, it was demonstrated that a telemedicine intervention with myIBDcoach significantly the baseline treatment adherence improved after a 12-months follow-up (estimated intervention effect of 0.46, 95% IC 0.22 to 0.70; p=0.0002), much more than others health outcomes as HRQoL or disease-related knowledge. Available IBD MAHS consider more clinical care features than mainly education: monitoring, treatment, follow-up, patients' emotions, even bathroom localisation through GPS function.

Problem statement A low disease-related knowledge can influence treatment adherence and compliance in IBD patients, impacting clinical, occupational and social conditions. In the Romanised World, the association between disease-related knowledge and treatment adherence and compliance in IBD patients, or even social issues as work disability, as to how they interact with ICTs for clinical purposes, seems to be more understood in Europe and North America than Latin America. In the last, a better comprehension of these situations is required in order to improve existing treatment adherence and compliance. This context requires more prospective studies in a region with epidemiologic, ethnic and cultural particularities as Latin America, with a rising IBD annual incidence.

An IBD MAHP can play an essential role in reinforcing treatment adherence and compliance in Latin American IBD patients. However, most of the available IBD MAHS is hard-handled, non-validated or non-Spanish language resources. To date, there is only three available in Spanish, but developed in Spain: one in Pediatrics (miEII-PED), and another two addressed to adults patients but still on the validation process (TeleCumple and TECCU). ICTs have demonstrated improved IBD treatment adherence and compliance. Nevertheless, IBD MAHS deserves to be more validated and in the corresponding language and cultural context. We hypothesise that a locally designed, easy-handled IBD MAHS improves IBD-related knowledge and treatment adherence and compliance on IBD patients.

Aims and Scope:

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 an Argentinian 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.

Materials and methods Study design and settings The DAMASCO trial (Development and Assessment of a Mobile App for Sanitary Support of Spanish-Speaking' with Crohn's and ulcerative Colitis) comprehends three stages. Stage I corresponds to a survey-based prospective cohort observational trial of out-patients in whom IBD-related knowledge level, treatment adherence, compliance, and ICTs preferences and barriers will be assessed in IBD patients. Stage II and III correspond to the design and health outcomes validation of a Spanish-based IBD-MAHP through qualitative study and a randomised trial, respectively.

The DAMASCO trial has been initially conceived as a monocentric study with the participation of IBD patients attended by the Bowel Team, Gastroenterology Service of Hospital Nacional Profesor Alejandro Posadas (HNPAP), El Palomar, Buenos Aires - Argentina, between May 2021 to August 2022. However, the authorship does not discard the future participation of other Argentinian or even from other Latin American Spanish-speaking countries. For the moment, oral confirmation has been obtained from the followings: Instituto Ecuatoriano de Enfermedades Digestivas (IECED, Guayaquil - Ecuador) and Hospital Nacional Cayetano Heredia (HNCH, Lima - Perú). Due to the COVID-19 Pandemic and further worldwide and local politics around the Social Distancing, Quarantine and Isolation, it is foreseen that the study will be started in the second trimester of 2021, during the following two years.

Population Data search strategy. During May 2021, it will be requested to the Department of Statistics and Censuses of each participating centre, records of in-patients and out-patient attention between January 2016 to December 2020 due to the following presumptive or definitive diagnosis following the 10th revision of the International Classification of Diseases (ICD-10): Crohn's disease (ICD-10 K50.0, K50.1, K50.8 and 50.9), ulcerative colitis (ICD-10 K51.0, K51.1, K51.2, K51.3, K51.4, K51.5, K51.8, K51.9), indeterminate colitis or IBD unclassified (ICD-10 K52.3). Selection criteria will be explained below.

Procedure Database recovering and recruitment of patients. A dataset concerning an IBD patients' list attended at each participating centre will be finally performed following selection criteria detailed above, avoiding duplicated cases. For stage I, patients will be recruited by phone or email invitation through the contact information available at corresponding hospital records, but also by personal invitation during Gastroenterology consultation, as long as they belong to the pre-established IBD patients' list. Patients' recruitment will comprehend the acceptance of answering corresponding surveys, which will be available in sheet forms or in an electronic version based on the SurveyMonkey platform. Surveys will comprehend baseline data, IBD-related knowledge, treatment adherence and compliance and ICTs preferences and barriers (explained below).

Focus group and IBD 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. 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.

Statistical analysis Technical considerations. M.A.P.T. will perform the Statistical Analysis using the latest available R version (R Foundation for Statistical Computing; Vienna, Austria). A p\<0.05 will be considered to be statistically significant, but for the univariate-analysis assessment, it will be regarded as a p\<0.2, when appropriated.

Sample size. Due to that previously mentioned topics are still pending for larger description among the Latin American population, it is preferred to estimate sample sizes for exploratory analysis. The total number of patients registered in the prospective IBD database of a digestive centre in La Argentina (n=4000) has been considered as a reference for the universe. It has been decided a margin of error of 5% and a confidence interval (CI) of 95%. Proportions estimation considers finite population correction, and it has been calculated using the R function sample.size.prop.

* Considering that around 29% of Chilean IBD patients answered correctly more than 50% of CCKNOW, the sample size for estimating this IBD-related knowledge level rate on our population will be n=294.
* Considering that around 50.3% of Argentinian IBD patients have inadequate treatment adherence, the sample size for estimating the rate of treatment adherence and compliance in our population will be n=351.
* Considering that around 16.7% of American IBD patients use social media to obtain or post IBD-related information, the sample size for estimating this aspect on our population will be n=203.

Descriptive analysis. Quantitative variables will be described in means (standard deviation, SD) or median (minimum-maximum range) following statistical distribution (Kolmogórov-Smirnov test). Qualitative variables will be described in frequency (%), and the 95% CI will be calculated when necessary.

Inferential analysis:

* Psychometrical testing of QUECOMIICAT: Cronbach's alpha coefficient, principal component analysis (PCA), test-retest reliability.
* Association between QUECOMIICAT and SEAMS: linear regression.
* Risk factors modelling: univariate and multivariate are based on logistic regression (OR, Odds Ratio).

Ethics The DAMASCO trial (stage I) has been approved by the Institutional Review Board (IRB) of the HNPAP. In order to use the previously mentioned surveys, the authorship has obtained corresponding authorisation from the authors of QUECOMIICAT questionary, Spanish-validated version of SEAMS, and surveys which inspired designed ICTs preferences and barriers instrument used on this research. Enrolled patients will sign an informed consent before answering respective surveys along stage I. A brief study explanation will be attached to the surveys. Stage II and III ethic aspects will be discussed after stage I preliminary findings and detailed in a subsequent research proposal. Patient identity and record confidentiality will be granted as described by Law Nº 25.326 Personal Data Protection (Ministry of Justice and Human Rights, Argentine Republic). The study will be conducted in adherence to the 1947 Nuremberg Code and the 1964 Declaration of Helsinki, and later amendments (the latest in 2013).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: IBD-related knowledge level
timeFrame: One year
measure: Treatment adherence and compliance
timeFrame: One year
measure: Information and communication technologies preferences and barriers
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Miguel Angel Puga Tejada
Study officials:
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