- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07584408
Feasibility of the Glenrose Grocery Game for Cognitive and Functional Outcomes in Older Inpatients
The Effects of Playing the Glenrose Grocery Game on the Specific Mental Functions Andfunctioning in Inpatient Older Adults: a Feasibility Study
Older adults could benefit from computer serious games as a strategy for improving not only their cognitive functions but also their functioning and performance in daily activities, which are often compromised with age. A computer serious game is one designed for a primary purpose other than pure entertainment. Few computer games had been developed to emulate instrumental activities of daily living (IADLs), such as money management (e.g., shopping or paying bills). To fill this gap, occupational therapists at the Glenrose Rehabilitation Hospital (GRH) developed the Glenrose Grocery Game (GGG).
At the time, the game had not yet been tested. Thus, the purpose of this feasibility study was to explore whether playing the GGG as part of the rehabilitation program at the GRH had an effect on specific mental functions (memory and attention), occupational performance in money management tasks, and satisfaction with occupational performance in older adults.
In this study, we compared the outcomes of 7 participants who played the GGG (intervention group) with those of 8 different participants who received the GRH standard of care (control group). Data analysis is being conducted. The results of the study:
Provided clinicians with evidence for implementing the GGG in interventions, which in turn may benefit inpatient clients at the GRH;
Informed stakeholders' decisions about clients' safe discharge and transition to home and community; and
Supported researchers in designing a larger and more robust study.
연구 개요
상태
상세 설명
Occupational therapists at the Glenrose Rehabilitation Hospital (GRH) developed the Glenrose Grocery Game (GGG)-a serious game designed to simulate shopping, meal planning, and budgeting in a virtual environment. However, the GGG had not yet been tested for its impact on cognitive and occupational outcomes.
The purpose of this feasibility study was to explore the implementation and effects of the GGG as part of the rehabilitation program at GRH, assessing its impact on specific mental functions, occupational performance, and satisfaction with performance in older adults. The study also aimed to estimate the parameters needed to design a future randomized controlled trial (RCT).
Research Questions
Was the designed protocol feasible for conducting a future definitive RCT?
Did playing the GGG as part of the rehabilitation program at GRH affect mental functions, occupational performance, and satisfaction in older adults, compared to standard care?
How engaged were older adults while playing the GGG?
Methods Design A pretest-posttest control group design was used. The experimental group received sessions with the GGG, while the control group received standard care (i.e., compensatory strategies). The study followed the CONSORT guidelines for randomized pilot studies (Eldridge et al., 2016).
Participants
Inclusion Criteria:
Adults aged 50 or older
With or without cognitive impairment (MOCA ≥19)
Functional vision and hearing (with or without aids)
Functional upper extremity use
Required no more than one-person assist for mobility
Exclusion Criteria:
Diagnosed with influenza or a virus affecting cognitive performance
Unable to count, speak, or follow simple English instructions
Sample Size Based on power analysis (α = 0.05, power = 0.8, effect size = 1.2), a minimum of 32 participants was required. We aimed to recruit 16 participants per group to account for a 25% dropout rate.
Sampling and Allocation Stratified permuted block randomization was used, with stratification based on MOCA scores. Participants with MOCA scores between 19-24 were categorized as having moderate cognitive impairment; those with scores of 25-30 were considered to have mild/no impairment. Allocation was blinded to research staff administering and evaluating the intervention.
Recruitment Protocol OTs at GRH inpatient units identified eligible participants. Informed consent (or assent via substitute decision-makers) was obtained. Allocation and coding were conducted by the PI (AMRR), and group assignment remained blinded to those delivering and evaluating the intervention.
Independent Variable
GGG Intervention: Participants played the GGG, completing meal planning and grocery shopping tasks in a gamified format. Sessions (8 × 30 minutes over 4 weeks) were delivered by trained RAs using tablets or computers.
Standard Care: Included cognitive assessment, education, and compensatory strategies (e.g., journaling, memory logs). Interventions were tailored to comprehension level and included caregiver involvement when needed.
Dependent Variables
Specific Mental Functions:
Trail Making Test (TMT) Parts A and B
Walking and Remembering Test (WART)
Montreal Cognitive Assessment (MOCA)
Occupational Performance:
Objective: PASS Task H8 (Money Management: Shopping)
Subjective: Canadian Occupational Performance Measure (COPM)
Engagement:
8-point Likert engagement scale developed in a prior study (Ríos Rincón et al., 2017)
All tools have strong metric properties and are suitable for use with older adults.
Data Collection The experimental group received GGG sessions in a dedicated room at GRH. Engagement was assessed post-session. All participants completed pretest and posttest assessments, taking ~80 minutes total. Blinded evaluators (RA 2) conducted assessments; a second rater (RA 3) scored at least 25% of measures to ensure reliability.
Data Analysis Data are currently being analyzed using SPSS under intention-to-treat principles. Descriptive statistics are being used to characterize the groups at pretest. Due to the small sample size, non-parametric tests (Wilcoxon signed-rank and Mann-Whitney U) are being used for within- and between-group comparisons for MOCA, TMT, WART, PASS, and COPM scores. Clinical significance in COPM scores is being evaluated using the two-point threshold (Law et al., 1998). Engagement data are being analyzed descriptively.
Potential Impact Findings from this study will provide clinicians with preliminary evidence regarding the GGG's impact on cognition, occupational performance, and engagement in older adults. If results are favorable, they will support the implementation of the GGG as a rehabilitation tool at GRH, benefiting inpatient clients. Insights will also help guide discharge planning and caregiver support and inform the design of a future, larger-scale RCT.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Alberta
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Edmonton, Alberta, 캐나다, T6G 2G4
- Glenrose Rehabilitation Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Older adults aged 50 years and older
- With and without some level of cognitive impairment (Montreal Cognitive Assessment (MOCA) ≥19) (Nasreddine, Phillips, & Chertkow, 2011).
- Have a level of awareness to be able to interact with the game platform.
- Have functional vision and hearing with or without aides (glasses/hearing aides) to be able to interact with the game platform.
- Have functional upper extremity function to be able to interact with the game.
- Maximum mobility limitation of 1 person assist with mobility aid
Exclusion Criteria:
- Older adults who have Infuenza or another virus virus that affect their performance
- Unable to count, speak (name objects and say numbers) or comprehend simple instructions in English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Standard of care for cognitive impairment
Compensatory strategy consists in recommendations made by Occupational Therapists to the client and caregivers for his/her safety while performing instrumental activities of daily living.
|
Compensatory strategies
|
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실험적: Experimental: Glenrose Grocery Game sessions
Participants played the GGG, completing meal planning and grocery shopping tasks in a gamified format.
Sessions (8 × 30 minutes over 4 weeks) were delivered by trained RAs using tablets or computers.
|
Participants played the the Glenrose Grocery Game (a serious game), completing meal planning and grocery shopping tasks in a gamified format.
Sessions (8 × 30 minutes over 4 weeks) were delivered by trained RAs using tablets or computers.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Montreal Cognitive Assessment (MOCA)
기간: From enrollment to the end of treatment at 4 weeks
|
The MOCA is a widely used screening tool for detecting mild cognitive impairment.
It assesses several cognitive domains, including memory, attention, language, visuospatial skills, and executive function.
A score of 26 or above is considered normal.
|
From enrollment to the end of treatment at 4 weeks
|
|
Trail Making Test (TMT) Parts A and B
기간: From enrollment to the end of treatment at 4 weeks
|
The TMT assesses visual attention, processing speed, mental flexibility, and executive function.
Part A involves connecting numbered circles in sequence, while Part B alternates between numbers and letters (e.g., 1-A-2-B), requiring set-shifting ability.
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From enrollment to the end of treatment at 4 weeks
|
|
Walking and Remembering Test (WART)
기간: From enrollment to the end of treatment at 4 weeks
|
The WART is a dual-task assessment that evaluates divided attention and working memory.
Participants walk a defined path while recalling and repeating a sequence of numbers, simulating real-world multitasking challenges.
|
From enrollment to the end of treatment at 4 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Engagement scale
기간: After each session with the game from enrollment to the end of treatment at 4 weeks
|
This is an 8-item scale for engagement
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After each session with the game from enrollment to the end of treatment at 4 weeks
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Objective Measure - PASS Task H8 (Money Management: Shopping)
기간: From enrollment to the end of treatment at 4 weeks
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This task from the Performance Assessment of Self-Care Skills (PASS) evaluates a person's ability to complete a simulated shopping task, focusing on problem-solving, planning, and safety in money management.
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From enrollment to the end of treatment at 4 weeks
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Canadian Occupational Performance Measure (COPM)
기간: From enrollment to the end of treatment at 4 weeks
|
The COPM is a client-centered tool that captures self-perceived performance and satisfaction with daily activities.
Clients identify priority tasks, then rate their performance and satisfaction on a 10-point scale.
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From enrollment to the end of treatment at 4 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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