Perspectives on the Multidisciplinary Approach to Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study With Patients From the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Perceptions
研究概览
简要总结
The aim of this qualitative study is to explore and identify the expectations, perceptions, attitudes, needs, and knowledge related to the management of metabolic dysfunction-associated steatohepatitis (MASH) in patients diagnosed with this condition, before and after their participation in the MASH-Cardiovascular Programme at Hospital de la Santa Creu i Sant Pau, Barcelona.
The main research question is:
What expectations, attitudes, needs, and perceptions do patients with MASH participating in the MASH-Cardiovascular Programme exhibit before and after the intervention?
Participants will undergo two semi-structured interviews: one prior to, and one following, their involvement in the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme.
- •Patients followed in the outpatient hepatology/gastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F
- •Patients aged between 18 and 75 years.
- •Patients with a BMI ≥ 27 kg/m².
- •Patients who consent to participate in the study-specific interviews.
排除标准
- •Patients who do not agree to participate in the study-specific interviews.
- •Patients meeting exclusion criteria of the MASH-Cardiovascular Programme:
- •Patients with decompensated liver cirrhosis.
- •Patients who are vegetarians or have dietary habits/preferences that prevent adherence to standard-of-care nutritional guidelines.
- •Patients with moderate-to-severe alcohol consumption (>20 g/day for women and >40 g/day for men).
- •Patients with an eGFR < 30 mL/min.
- •Patients with malnutrition.
- •Patients with type 1 diabetes or other forms of diabetes.
- •Patients who are candidates for bariatric surgery.
- •Patients with active malignancy.
- •Patients with advanced or unstable heart failure.
- •Patients with eating disorders or severe psychiatric illness.
- •Patients currently enrolled in another clinical trial.
- •Pregnant women or women planning to become pregnant.
结局指标
主要结局
Perceptions
时间窗: At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)
Perceptions explored through semi-structured interviews
Attitudes and expectatives
时间窗: At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)
Attitudes and expectatives explored through semi-structured interviews
MASH-related knowledge
时间窗: At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)
MASH-related knowledge explored through semi-structured interviews
Unmet needs
时间窗: At baseline (within two weeks before starting the programme) and at one-year follow-up (within two weeks before and after completing the programme)
Unmet needs explored through semi-structured interviews
次要结局
未报告次要终点