Role of Information and Communication Technologies for Health Support in Inflammatory Bowel Diseases: The DAMASCO Trial (Stage I)
试验速览
- 阶段
- 不适用
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- IBD-related knowledge level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
IBD-related knowledge level
时间窗: One year
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.
Information and communication technologies preferences and barriers
时间窗: One year
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.
Treatment adherence and compliance
时间窗: One year
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.
次要结局
未报告次要终点