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临床试验/NCT05422339
NCT05422339已完成不适用

Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology

MapHabit, Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in User Interaction and Engagement From Baseline to 6 Months

研究概览

简要总结

As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system's gamification is investigated to determine whether the assistive technology facilitates user engagement and retention. Additionally, the study will examine if the gamified software improves the quality of life of persons with dementia and reduce the burden of the respective care partners. Participants will be individuals with Alzheimer's disease or related dementias in mild to moderate stage of cognitive impairment, accompanied by their respective primary care partner (i.e., primary familial caregiver). The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) experimental condition in which MHS+Gamification is implemented into the daily care received by participants 2) control condition in which the MHS alone and separate engagement material is incorporated into the participant's daily care. Sample size goal will strive for a total of 40 individual-caregiver dyads, 20 in each condition. The study duration will be a 6-month intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
  • •Participating caregiver of individual with dementia must be the primary caregiver
  • •Proficient in English

排除标准

  • •Individual not diagnosed with ADRD
  • •Participating caregiver of individual with dementia is NOT the primary caregiver
  • •Not proficient in English

研究组 & 干预措施

Gamified Intervention

Experimental

This condition involved the implementation of an assistive technology software (the MapHabit system) with added gamification features into the daily care of the participants. The experimental condition received the version that incorporates gamified content and structure. Gamification involved receiving four new cognitive games each month. The cognitive games that were chosen for the current study followed game types observed to be prevalent in literature centered on serious games within dementia research. These games aim for cognitive stimulation in slowing down symptom acuity. Game design elements of positive reinforcement, problem-solving, progression, and visual cues were implemented into game content and software.

干预措施: The MapHabit system (MHS) (Device)

Non-gamified Intervention

Active Comparator

This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, will be given to a separate group of participants with mild to moderate stage of ADRD. The difference here will be that the software will be a version that does not include gamification features. The Control Group watched several 40 to 55-minute educational videos that were sent to the participants' devices each month. The content involved topics such as Happiness, Memory, Nutrition/Diet, and Mindfulness. The intent was to have the two groups engaged for about equal lengths of time in each of their respective interventions.

干预措施: The MapHabit system (MHS) (Device)

结局指标

主要结局

Change in User Interaction and Engagement From Baseline to 6 Months

时间窗: User engagement (i.e., map count) was collected daily for the total duration of 180 days/6 months of the subject's participation. Usage data was segmented and analyzed via monthly basis.

Our internal analytics of the software can assess the user's interactions with the application by tracking user's map use count per month. By combining these data points, we can determine the average engagement for each participant and compare them between groups.

Quality of Life-18 (QoL-18)

时间窗: The instrument was administered to the participants once -- at the end of their participation in the 6 month study.

18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-5. A higher number indicates better outcome.

次要结局

  • 2-item Satisfaction Scale (SS-2)(The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months))

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Stuart Zola

Chief Scientific Officer

MapHabit, Inc.

研究点 (1)

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