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Trial record 39 of 125 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Spain )

iGame Randomized Control Trial Protocol

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ClinicalTrials.gov Identifier: NCT04019119
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Horizon 2020 - European Commission
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga

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 both primary prevention of health (reduce sedentary lifestyle and promote physical activity), such as secondary prevention in three clinical subtypes of noncommunicable diseases, where lifestyle modification is the center of its best practice.

Condition or disease Intervention/treatment Phase
Low Back Pain Oncology Depression Sedentary Lifestyle Sedentary Behavior Behavioral: Digital intervention Not Applicable

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, (Edwards et al., 2016). 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 (Michie et al., 2013).
  • 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 (Hoeppner et al., 2016).
  • Little participation of researchers in health, professionals and participation of the end user in the process of gamification development (Wolf et al., 2013). 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups study. One group with intervention (app mobile program); second group as control. At the end of the intervention, the control group receives advice of demonstrated effectiveness in the intervention to comply with the ethical principles.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The system of randomization for the participants is through an external computer system.
Primary Purpose: Treatment
Official Title: Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Primary and Secondary Prevention: iGAME Controlled Randomized Clinical Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: Digital intervention
The information group will receive through a mobile application tips to reduce sedentary lifestyle and promote healthy living habits.

No Intervention: 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.



Primary Outcome Measures :
  1. Energy Expenditure [ Time Frame: 24 hours a day for a week. These varaible will be measure 3 times. At the beginning of the study. At the end of the intervention (3 months from the beginning of the study). One year after the beginning of the study. ]
    Energy consumption measured by accelerometry: energy consumption will be evaluated through the configuration and installation of accelerometer devices equipped in a bracelet.


Secondary Outcome Measures :
  1. International Physical Activity Questionnaires (IPAQ) [ Time Frame: 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. ]
    Patient reported outcome: Physical activity related to a person's health

  2. International Sedentary Assessment Tool (ISAT) [ Time Frame: 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. ]
    Patient reported outcome. It is an evaluation of sedentary behavior. An alternative way to the use of accelerometry for the calculation of energy consumption.

  3. EuroQol 5 dimensions (EQ-5D) [ Time Frame: 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. ]
    Patient reported outcome. Health index that relates quantity and quality of life

  4. MEDRISK [ Time Frame: 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. ]
    Patient reported outcome: tool designed to assess patient satisfaction with physiotherapy care through intrinsic and extrinsic factors.

  5. Piper Fatigue Scale (PFS). Oncology breast survivors subgroup [ Time Frame: 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. ]
    Patient reported outcome:Questionnaire designed to evaluate cancer-related fatigue in breast cancer survivors. Composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue: behavioral/severity, affective meaning, sensory and cognitive/mood. To calculate the total fatigue score, add the 22-item scores together and divide by 22 in order to keep the score on the same numeric "0" to "10" scale. Severity codes: 0 none, 1-3 mild, 4-6 moderate, 7-10 severe.

  6. Fear-avoidance Components Scale (FACS). Oncology breast survivors subgroup [ Time Frame: 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. ]
    Patient reported outcome: quantification of existing fear-avoidance components in patients with medical conditions associated with pain. 20 question related to painful medical condition. 5 = Completely Agree 4 = Mostly Agree 3 = Slightly Agree 2 = Slightly Disagree 1 = Mostly Disagree0 = Completely Disagree. Higher values represent a worse outcome.

  7. Rolland-Morris Questionnaire (RMQ). Low back pain subgroup [ Time Frame: 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. ]
    patient reported outcome. Assessment the degree of physical disability related to non-specific low back pain, understanding physical disability as limitation in the performance of activities of daily life.

  8. Spine Functional Index (SFI). Low back pain subgroup [ Time Frame: 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. ]
    Patient reported outcome.Assessment the functionality of the column as a whole

  9. MINI Interview. Depression Subgroup. [ Time Frame: Only once, at the beginning of the study. ]
    Brief structured diagnostic interview to generate diagnoses DSM-IV and ICD-10

  10. PHQ-9 [ Time Frame: 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. ]
    Patient reported outcome. Assessment the presence and severity of depressive symptoms, relating to the last days of the previous week.


Other Outcome Measures:
  1. Age [ Time Frame: At the beginning of the study ]
    years old

  2. Gender [ Time Frame: At the beginning of the study ]
    Male or female.

  3. Height [ Time Frame: At the beginning of the study ]
    measure in meters

  4. Weight [ Time Frame: At the beginning of the study ]
    measure in kg

  5. Body mass index (BMI) [ Time Frame: At the beginning of the study ]
    kg/m2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for sedentary group:

  • 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

Inclusion 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

Exclusion Criteria:

  • Several mental illness
  • Several illness that limits physical ability
  • Phobia for digital technologies
  • Difficulty in attending study measurements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019119


Locations
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Spain
Antonio Cuesta Vargas
Málaga, Spain
Sponsors and Collaborators
University of Malaga
Horizon 2020 - European Commission

Publications:
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Responsible Party: Dr. Antonio I Cuesta-Vargas, Principal Research, University of Malaga
ClinicalTrials.gov Identifier: NCT04019119     History of Changes
Other Study ID Numbers: 823871-iGame
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results emerging from this study are positive, negative or inconclusive with respect to the proposed hypothesis, these will be attempted to publish as scientific production in journals of high impact in the area of knowledge and indexed in Journal Citation Reports of ISI-Thompson, preferably of the 1-2th quartile. In addition, we will try to select Open Acess journals to favor the scientific dissemination of the results. In the same way, the results will be exposed in communications, papers, forums and discussion tables of different scientific and cultural days.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Free access since its publication in impact journals (Q1 - Q2).
Access Criteria: Open access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms