Clinical trial NCT05970835: Validation of a Mobile App as an Adjuvant Treatment
Official title: Validation of a Mobile App as an Adjuvant Treatment for Thermal Context Patients: a Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Validation
Keywords: thermalism
tourism
assessment
clinical
Lead sponsor: ISAVE- Instituto Superior de Saúde
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a single-blinded, parallel two-arm group randomised, controlled, superiority trial with a 3 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Balance evaluation
timeFrame: From baseline until the last up to 9 months
measure: Functional ability
timeFrame: From baseline until the last up to 9 months
Secondary outcomes:
measure: Dyspnea
timeFrame: Through the study completion, an average 1 year
measure: Evaluate pain
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Amares
country: Portugal
facility: ISAVE
state: Braga
Study officials:
affiliation: ISAVE- CICS
name: Andrea Ribeiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: