Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Secondary Prevention: iGAME Controlled Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of Malaga
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in International Physical Activity Questionnaires (IPAQ)
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
The objective of the project is to analyze the clinical effectiveness of a gamifield mHealth application (iGAME) and developed in the context of lifestyle modification, but with the approach of the Behaviour Change Technique, through a randomized clinical trial that affects secondary prevention in three clinical subtypes of noncommunicable diseases, where lifestyle modification is the center of its best practice.
Detailed Description
Despite digital exposure, gamification of health has been widely understood and often applied ad hoc in health products. Attempts to incorporate game concepts into digital health applications have not led to demonstrated success. Recent studies have shown that only 4% of the best rated health apps in Apple stores and Google Play (based on revenue and download) have gamification elements, but less than 5% of these health apps have been included in the application library of National Health Service. In addition, very little of 5% was developed for industry and health professionals. If the power of digital technologies, such as games for clear clinical benefits, is not released, opportunities for social and economic burial will be lost for all stakeholders in the digital health and digital economy ecosystem. A number of factors in this barrier: * The best techniques for the design of activities. The majority of health gamification has little consistent support of health or clinical theories. * The high cost and complexity of the digital game development process. The majority of gaming functions are based on best practices in the development of digital games. * Little participation of researchers in health, professionals and participation of the end user in the process of gamification development. Very little health gamification is formally evaluated clinically. The initial hypothesis is that after 12 weeks of participation in the original iGAME application, participants will increase the quantity and distribution of energy consumption, through the estimation of results, data based on acceleration and questionnaires. automatic information In addition, it will also improve satisfaction and lifestyle, as well as the consumption of health services.
Investigators
Dr. Antonio I Cuesta-Vargas
Principal Research
University of Malaga
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Several mental illness
- •Several illness that limits physical ability
- •Phobia for digital technologies
- •Difficulty in attending study measurements
Outcomes
Primary Outcomes
Change in International Physical Activity Questionnaires (IPAQ)
Time Frame: Change from baseline amount of physical activity at 3 months
Patient reported outcome: Physical activity related to a person's health
Secondary Outcomes
- Piper Fatigue Scale (PFS). Oncology breast survivors subgroup(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- Fear-avoidance Components Scale (FACS). Oncology breast survivors subgroup(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- MINI Interview. Depression Subgroup.(Baseline)
- International Sedentary Assessment Tool (ISAT)(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS)(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- Rolland-Morris Questionnaire (RMQ). Low back pain subgroup(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- Spine Functional Index (SFI). Low back pain subgroup(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- European Quality of Life-5 Dimensions (Euroqol-5D, EQ-5D)(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- PHQ-9(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)
- International Physical Activity Questionnaires (IPAQ)(Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.)