Validation of a Mobile App as an Adjuvant Treatment (VMA)

ISAVE- Instituto Superior de Saúde

Status: Enrolling

Conditions: Validation

Treatments: Other: Control group; Other: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT05970835

ISAVE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults, in treatment at Complexo Termal de Caldelas- Amares, Portugal,
• with chronic musculoskeletal problems
• respiratory issues
• with satisfactory cognitive analysis for exercise

Exclusion criteria

• having received intramuscular or intraarticular steroid injections within 4 weeks, pregnancy, moderate or severe cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Control group

Experimental group

Experimental group

Description:

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.

Treatment:

Other: Experimental group