NCT05970835

Validation of a Mobile App as an Adjuvant Treatment

Validation of a Mobile App as an Adjuvant Treatment for Thermal Context Patients: a Randomized Controlled Trial Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ISAVE- Instituto Superior de Saúde · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Validation

Interventions

Type	Name	Description
OTHER	Control group	Participants assigned to control group will receive the usual care provided by clinicians and physiotherapists from the Complexo Termal de Caldelas. Participants 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. data collection will be conducted in moments t2 and t3 by a phone call.
OTHER	Experimental group	Experimental group evaluation: balance, functionality- 30 Second Sit To Stand Test, Modified Medical Research Council and functional status questionnaire, pain using VAS, cognitive variables-Montreal Cognitive Assessment and self-reported thermal water effects.After evaluation the App will display exercises related to data collected. Outcome measures will be collected at baseline, and 1 week, 1 month and 3 months after baseline. After evaluation the App will display exercises related to data collected concerning participants condition improvement.

Timeline

• Start date: 2023-07-05
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

1 site across 1 country: Portugal