Validation of a Mobile App as an Adjuvant Treatment

NCT05970835 | Unknown DMC

• 1 other identifier: ISAVE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Validation

Keywords

thermalism; tourism; assessment; clinical

Outcome Measures

Primary Outcomes (2)

• Balance evaluation

  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

  From baseline until the last up to 9 months

• Functional ability

  The participant is encouraged to complete as many full stands as possible within 30 seconds.

  From baseline until the last up to 9 months

Secondary Outcomes (2)

• Dyspnea

  Through the study completion, an average 1 year

• Evaluate pain

  through study completion, an average of 1 year

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Control group

Experimental group

EXPERIMENTAL

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.

Other: Experimental group

Interventions

Control group OTHER

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.

Control group

Experimental group OTHER

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.

Experimental group

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ISAVE- Instituto Superior de Saúde: lead

Study Sites (1)

ISAVE

Amares, Braga District, 4720-155, Portugal

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Andrea Ribeiro, PhD

  ISAVE- CICS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Ribeiro, PhD

CONTACT

+351967441378; andrea.ribeiro@isave.pt

Mafalda Duarte, PhD

CONTACT

+351964843139; mafalda.duarte@isave.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will remain blinded to participant´s allocation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: July 5, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)