Feasibility and Usability of Mobile Applications for Monitoring Cutaneous Leishmaniasis Treatment in Colombia: 2019-2021
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The effectiveness of community-based intervention using the Guaral+ST mobile application was evaluated by four outcomes: i. The number of follow-ups
研究概览
简要总结
An effectiveness-implementation sequential explanatory hybrid design type 2 was performed in two rural communities of Colombia. A quasi-experimental study with historical control (standard of care) was designed to estimate the effectiveness of community-based intervention using the Guaral+ST mobile application (app). Three implementation outcomes were evaluated: acceptability and usability by qualitative methods, and fidelity by quantitative methods
详细描述
An effectiveness-implementation sequential explanatory hybrid design type 2 using mixed methods was performed in 2020 and 2021 in two study sites: Pueblo Rico, Risaralda, and Rovira, Tolima. A quasi-experimental study with historical control (standard of care) was designed to evaluate the effectiveness of the community-based intervention supported by mHealth, in terms of monitoring of treatment of patients with cutaneous leishmaniasis. The effectiveness indicators i. number of follow-up contacts, ii. Adherence to treatment, iii. adverse drug reactions, and iv. the therapeutic response were compared between the intervention and control groups.
After the effectiveness evaluation was completed, three outcomes were assessed to inform the implementation of the community-based use of the app: acceptability, usability, and fidelity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients followed by CHL with the app (effectiveness evaluation):
- •Diagnosis confirmed by microscopy of tissue smear or culture
- •Any age and gender
- •Medical prescription for antileishmanial treatment
- •Approved and signed informed consent
- •Availability of CHL to monitor treatment of the patients in the community
- •Inclusion Criteria patients who received the standard of care (effectiveness evaluation):
- •Clinical records of patients with confirmed CL at most two years prior to the start of this study
- •Any age and gender
- •Received antileishmanial treatment based on national guidelines
- •Inclusion criteria for participants of implementation evaluation (Community Health Leaders)
- •Residents of the rural areas of study sites
- •Voluntary participation in the monitoring of patients using the mobile app
排除标准
- 未提供
研究组 & 干预措施
Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis
Patients with cutaneous leishmaniasis are followed with the Guaral+ST app by Community Health Leaders. This intervention was not randomized
干预措施: Community based strategy to follow-up pactientes with Cutaneous Leishmaniasis (Other)
Control group: Standard of care
Control group: Standard of Care: Registers historical patients with cutaneous leishmaniasis is followed in the health facility by physicians according to national guidelines.
结局指标
主要结局
The effectiveness of community-based intervention using the Guaral+ST mobile application was evaluated by four outcomes: i. The number of follow-ups
时间窗: 6 months
The number of follow-up contacts between patients and health system or community health workers.
iv. Therapeutic response
时间窗: 6 months
* Cure: Completely re-epithelialised lesions on days 90 -180 after initiation of treatment * Failure: \>50% increase in ulcer size from baseline at any time during evaluation or incomplete re-epithelialised on days 90-180
iii. Adverse drug reactions
时间窗: 6 months
Frequency of adverse drug reactions: number of adverse drug reactions
ii. Percent adherence to treatment
时间窗: 6 months
Relation between the number of doses administrated and the number of doses formulated by the physicians x 100.
次要结局
- iii. Fidelity(6 months)
- Implementation of the community-based strategy to follow patients with cutaneous Leishmaniasis was evaluated by three outcomes. i. Acceptability(6 months)
- ii. Usability(6 months)