Clinical trial NCT03643237: Gaming Applied to the Promotion of Active Aging
Official title: Gaming Applied to the Promotion of Active Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Aging Problems
Keywords: video game
older adults
active aging
health promotion
study protocol
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Center for Industrial Technological Development of Spain
First posted: 2018-08-22
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Active aging programs have been recommended by the World Health Organization to help deal with the progressive aging of the population. However, older adults have difficulties in accessing these programs. Online video game-based interventions would improve their accessibility, while complementing these interventions with a mobile application (App) would increase adherence and professional monitoring. The main objective of this study is to assess the efficacy of an interactive, online, video game-based cognitive behavioral intervention with an App companion for active aging compared to a control group receiving therapeutically inactive information. The secondary objectives are to: (a) analyze the moderators of the change in the outcome variables and (b) evaluate adherence to the intervention.

A randomized controlled trial will be performed including healthy adults older than 44. Recruitment of 180 participants is planned, with random allocation to one of the two conditions (90 participants per group): (a) an experimental group receiving an interactive, online, multimedia, video game-based cognitive behavioral intervention with an App companion (CCI-V) or (b) a control group receiving online therapeutically inactive information about active aging (CG).

The intervention will be administered in 8 weekly modules comprised of 45-minute sessions. A blind evaluation will be conducted through online self-administered tests at baseline, post-intervention, and 6- and 12-month follow-up. The primary outcome will be the health status. Secondary outcomes will be emotional well-being, symptoms of depression, reinforcement, negative thoughts, self-reported memory, cognitive tasks, sleep hygiene, physical activity, eating habits, body mass index (BMI), social support, dropouts, treatment adherence, and satisfaction with the intervention.

Detailed description: European population aging has increased in the last several decades: 19.1% of Europeans are currently older than 65, and 39.2% are over 50. Depression and dementia are some of the most prevalent conditions in older adults, and both have high socioeconomic costs. In this context, the World Health Organization has pointed out the importance of active aging promotion programs to help older adults maintain their independence and health for longer. In addition, healthy life habits such as physical activity and eating a balanced diet also help prevent disease and preserve mental and physical functions.

However, the lack of health care services for older adults, especially in rural areas which tend to have more older people, may limit access to active aging programs targeting depression, cognitive decline, and healthy habits. One way to overcome these barriers is through online video games that are accessible at home at any time with a low cost. However, the efficacy of video games in promoting active aging from middle to late adulthood has received very little attention in the literature.

A meta-analysis of 21 randomized controlled trials about video game-based interventions administered to healthy adults over 44 found that video game-based interventions produced positive effects on negative affect, objectively measured physical and social health with small effect sizes. However, the reviewed studies used non-standardized measures, and follow-ups were scarce. There was only one video game designed to prevent depression in older people. Furthermore, none of the reviewed studies involved integral interventions for emotional wellbeing, cognitive stimulation, or healthy life habits, even though a review of modifiable risk factors for dementia estimated that 51% of population-attributable risk was associated with cognitive inactivity, depression, physical inactivity, and obesity; and these midlife risk factors could be tackled early to prevent or delay the onset of dementia.

This study will assess the efficacy of an interactive, online, video game-based cognitive behavioral intervention to promote active aging from an integral health perspective, targeting emotional well-being, cognition, healthy life habits (sleep hygiene, physical activity, and eating habits), and social support.

Randomization will occur after screening and baseline assessments. An independent researcher (allocation concealment) will make allocation cards using computer-generated random numbers. He will keep the original random allocation sequences in an inaccessible location and will work with a copy. The randomization sequence will be communicated to the researchers in sealed numbered envelopes, one for each participant, with instructions to use them in numerical order.

Sample size calculation: We estimate that a sample size of 78 participants per group will be required, based on a previous meta-analysis of video game-based interventions for active aging reported effect sizes for mood and objectively measured physical health of 0.26 and 0.34, respectively, and another meta-analysis of video games for training cognition in older adults reported an effect size of 0.37, and assuming 80% power at a 0.05 (two-tailed) significance level and a mean of 8% attrition. To safeguard against an estimated 12% to 15% loss to follow-up, a minimum of 180 participants (90 in each group) must be recruited.

Ethics: Ethics approval has been obtained from the Bioethics Committee of the University of Santiago de Compostela (Spain), and the project complies with the Declaration of Helsinki. The confidentiality of all participants will be guaranteed. Participants will have to give their informed consent, which has been approved by the Bioethics Committee of the University of Santiago de Compostela (Spain).

Eligibility criteria: Inclusion Criteria:

* adult older than 44 years old living in the Region of Galicia (Spain)
* accessibility to a personal computer and a smartphone with internet connection
* informed consent to participate in the study
* commitment to conduct the program and complete subsequent evaluations

Exclusion Criteria:

* serious neurological or mental disorder (depressive disorder, schizophrenia, bipolar disorder, major neurocognitive disorder, dissociative disorders, substance abuse and/or dependence)
* physical or psychological problems that prevent study implementation (e.g., severe auditory and/or visual loss)
* recent psychological or psychiatric treatment (in the past 2 months)
* participation in another trial

Primary outcomes:
measure: Change from baseline Health Status to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
Secondary outcomes:
measure: Change from baseline Emotional distress to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Depressive symptomatology to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Reinforcement to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Negative automatic thoughts to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Self-reported memory to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Cognitive tasks
timeFrame: During the intervention sessions (8 weeks)
measure: Change from baseline Sleep hygiene behaviors to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Physical Activity to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Eating habits to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Body Mass Index to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Change from baseline Social support to post-treatment (9 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (9 weeks) with follow-ups at 6 and 12 months
measure: Drop outs and treatment adherence
timeFrame: During the intervention sessions (8 weeks)
measure: Satisfaction with the service received
timeFrame: Post-intervention (9 weeks)
Other outcomes:
measure: Socio-demographic characteristics
timeFrame: Pre-intervention
measure: Cognitive function
timeFrame: Screening
measure: Diagnostic Interview
timeFrame: Screening
Locations:
city: Santiago De Compostela
country: Spain
facility: Research Group on Mental Health and Psychopatology
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Fernando L. Vázquez González, PhD
role: PRINCIPAL_INVESTIGATOR
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