Validation of a Mobile App as an Adjuvant Treatment for Thermal Context Patients: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Functional ability
研究概览
简要总结
Health tourism is one of the most important touristic activities. It can generate economic and social value. Balneotherapy is one of the options concerning healthcare and well-being. Although this fact it lacks information concerning effectiveness of thermal water treatments. Digital Technologies are being implemented and developed in health care systems, stimulated also by World Health Organization (WHO), in order to facilitate and improve patients' treatment and assessment. Traditional approach does not allow a follow-up due to the fact the patient leaves the thermal complex after treatment or several other reasons due to that the gap persists and social security of each country avoids support based on this lack of information. It is important to fulfil this gap and for that digital technologies seem to be the answer.
This study aims to investigate effectiveness in self-management and clinical assessment and monitorization between a smartphone app (HealthSmArt_ISAVE) and a standard approach.
详细描述
This will be a single-blinded, parallel two-arm group randomised, controlled, superiority trial with a 12 months of intervention period in real thermal treatment conditions, in Caldelas, Amares, Portugal. The target population will be recruited among the patients who use the thermal environment in Caldelas- Amares.
The random sequence, with a 1:1 allocation of participants in control and intervention groups is going to be generated using an external website. The outcome data will be collected from stored data by a research assistant who is blinded to the treatment arm.
The study will be supported by clinicians, physiotherapists, and psychologists and will be developed in ISAVE in partnership with Complexo Termal de Caldelas.
The guideline SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) will be used for report elaboration and the manuscript will follow CONSORT (Consolidated Standards for Reporting Trials) guidelines for the transparent reporting of randomized trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcome assessors and data analysts will remain blinded to participant´s allocation group.
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, in treatment at Complexo Termal de Caldelas- Amares, Portugal,
- •with chronic musculoskeletal problems
- •respiratory issues
- •with satisfactory cognitive analysis for exercise
排除标准
- •having received intramuscular or intraarticular steroid injections within 4 weeks, pregnancy, moderate or severe cognitive impairment
研究组 & 干预措施
Control group
Firstly, all patients will be evaluated using Physical Performance Test, Saint George's Respiratory Questionnaire , and Geriatric Pain Measure and the MiniMental Satet Exam to fulfill the eligibility criteria. After that participants will be randomly assigned using the software www.randomizer.org. to control or intervention group. Outcome assessors and data analysts will remain blinded to participant´s allocation group.
Participants assigned to control group will receive the usual care provided by clinicians and physiotherapists from the Complexo Termal de Caldelas. They will have an educational session conducted by one of the researchers, and a paper sheet will be distributed with exercises and a written explanation of how to perform those exercises and the number of sets and repetitions.
干预措施: Control group (Other)
Experimental group
Concerning patients from the intervention group will have an educational session given by one of the researchers, explaining how to use the HealthSmArt_ISAVE App. Then each patient will be given a unique code and password to log into the App and to start working with their smartphones. HealthSmArt_ISAVE App has three main components which are: evaluation (short, medium and long term); screening and intervention/rehabilitation.
干预措施: Experimental group (Other)
结局指标
主要结局
Functional ability
时间窗: From baseline until the last up to 9 months
The participant is encouraged to complete as many full stands as possible within 30 seconds.
Balance evaluation
时间窗: From baseline until the last up to 9 months
Balance will be evaluated using Berg Balance Scale, composed by 14 items, Item-level scores range from 0-4, determined by ability to perform the assessed activity, Item scores are then summed, Maximum score = 56
次要结局
- Dyspnea(Through the study completion, an average 1 year)
- Evaluate pain(through study completion, an average of 1 year)