Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Secondary Prevention: iGAME Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in International Physical Activity Questionnaires (IPAQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The system of randomization for the participants is through an external computer system.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IInclusion Criteria for Breast Cancer Survivors subgroup:
- •Men and women
- •Age between 18 and 65 years
- •Sedentary behavior recognized by the subject: <1.5 METS per day and sitting> 4h / d .
- •Intention to change sedentary behavior manifested by the subject
- •Survivors of breast cancer. Women with a clinical history of diagnosis of primary breast cancer, having completed surgical treatment, radiotherapy or chemotherapy at least three months before starting the study intervention
- •Inclusion Criteria for Low Back Pain subgroup:
- •Men and women
- •Age between 18 and 65 years
- •Sedentary behavior recognized by the subject: <1.5 METS per day and sitting> 4h / d .
- •Intention to change sedentary behavior manifested by the subject
- •Mild low back pain of mechanical or degenerative cause diagnosed by a primary care physician
- •Inclusion Criteria for Depression subgroup:
- •Men and women
- •Age between 18 and 65 years
- •Sedentary behavior recognized by the subject: <1.5 METS per day and sitting> 4h / d .
- •Intention to change sedentary behavior manifested by the subject
- •Mild depression Diagnosis in Primary Care using the MINI interview to rule out another severe mental pathology and the PHQ-9 questionnaire to categorize the level of depressive severity
排除标准
- •Several mental illness
- •Several illness that limits physical ability
- •Phobia for digital technologies
- •Difficulty in attending study measurements
研究组 & 干预措施
Intervention: digital intervention Behaviour Change Technique
The assigned participants will receive an intervention based on gamification and the use of behavior change techniques to reduce sedentary lifestyle. Thus, a new mobile application will be used for 12 weeks that proposes to the user the realization of activities with the aim of reducing their sedentary behavior. The development of the application is based on previous analyzes that propose 6 clusters that encompass 33 factors that influence sedentary behavior. In this way, the application is designed to act on the two accessible: social support and behavior. On the social support, he proposes to the user to share his achievements in social networks or in an internal network of game users. In terms of habit modification, behavior modification strategies proposed in the Michie et al. (2013) taxonomy are applied, such as the following: establishment of personalized goals, rewards and reminders, awareness of achievements achieved, among others
干预措施: Digital intervention (Behavioral)
Control Group
The control group will receive the usual indications about the harms of sedentary lifestyle and the benefits of physical activity, not receiving specific intervention. In case the use of the intervention applied in the experimental group is beneficial, the participants assigned to the control group will be offered the opportunity to receive the intervention outside the study to allow the benefit to be used.
结局指标
主要结局
Change in International Physical Activity Questionnaires (IPAQ)
时间窗: Change from baseline amount of physical activity at 3 months
Patient reported outcome: Physical activity related to a person's health
次要结局
- 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.)
研究者
Dr. Antonio I Cuesta-Vargas
Principal Research
University of Malaga