LEAD IT! An App to Enable Persons With Early Stage Dementia to Lead Group Activities for Their Peers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
研究概览
简要总结
The proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, which is a tablet-based app designed to enable persons with dementia to lead activities for their peers (i.e., other persons with dementia). The study will examine the clinical outcomes of long-term use of the app by both Resident Leaders (RLs) and Resident Players (RPs).
The Specific Aims of the proposed Phase 2 project are to:
- Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months.
- Examine the extent to which RLs are able to serve as leaders while using LEAD IT!
- Examine the effects of resident-led LEAD IT! programming on RPs.
- Examine PWD and staff satisfaction with LEAD IT!
详细描述
he proposed Phase 2 project will involve the further development and evaluation of LEAD IT!, as well as examine the clinical outcomes of long-term use of the app by both RLs and RPs.
The Specific Aims of the proposed Phase 2 project are to:
- Develop improved Beta 1 and Beta 2 Versions of LEAD IT! with sufficient content to facilitate six activities twice per week for 4.5 months. During Months 1-7, the Beta 1 version of the app will be created by the study's Development Team (DT). During Months 13-15, the DT will create an improved Beta 2 version, based on lessons learned in Beta 1 testing.
- Examine the extent to which RLs are able to serve as leaders while using LEAD IT! During all intervention sessions, researchers will track the extent to which each RL follows key steps involved in leading each activity. RLs will be considered successful if they follow the steps 80% of the time and require less staff assistance on less than 20% of steps.
- Examine the effects of resident-led LEAD IT! programming on RPs. Two quasi-experiments will be conducted. Experiment #1, which will test the Beta 1 version of LEAD IT!, will use a pre-post design. Proximal (immediate) effects will be assessed by examining RP's levels of engagement/affect during baseline (standard) activities and again during LEAD IT! activities. It is hypothesized that LEAD IT! will result in higher quality engagement than baseline activities. Experiment #2, which will test the Beta 2 version of the app, will be a cluster randomized trial (CRT), consisting of pre- and post-intervention measurements of a Treatment Group (TG)-which will consist of PWD who receive the intervention - and a Control Group (CG) - which will consist of PWD who receive standard programming / care. Since Experiment #2 will occur after all improvements to the app have been made, it will represent the definitive trial of the LEAD IT! app's impact on PWD. For proximal (immediate) measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in positive forms of engagement, as compared to CG participants. For distal measures, it is anticipated that there will be a Group x Time interaction effect, with TG participants exhibiting significantly greater increases in quality of life (based upon the DEMQOL) at treatment, as compared to CG participants.
- Examine PWD and staff satisfaction with LEAD IT! This will be achieved by eliciting feedback from PWD and staff members. PWD and staff members will be considered "highly satisfied" with the app if 85% are satisfied with the app.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Persons with Dementia
- •Must reside in an Assisted Living Facility or NH
- •Must be at least 65 years old
- •Must speak and read English
- •Must have a clinical diagnosis of dementia (any type).
- •Resident-players must score at least five on the Mini-Mental State Examination (MMSE)
- •Resident-leaders must score at least 13 on the MMSE
- •Resident-leaders must possess at least 70% of the characteristics of successful leaders, based upon the I'm Still Here Skills Inventory, Short Edition, Modified
排除标准
- •for Persons with Dementia -the person shows signs of rapid cognitive decline or physical deterioration over the last six months, as evidenced by medical records.
- •Inclusion Criteria for Staff
- •Must be at least 18 years old
- •Must speak English
- •Exclusion Criteria for Staff
研究组 & 干预措施
Experimental: Experimental, LEAD IT! Programming
Participants in the Experimental / LEAD IT! arm will take part in LEAD IT! programming for 18 weeks. The programming will occur twice per week, for a total of 36 sessions.
干预措施: LEAD IT! Programming (Behavioral)
No Intervention: Control, Standard Care / Programming
Participants in the Control arm will receive standard care / programming.
结局指标
主要结局
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale [Time Frame: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
时间窗: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Constructive Engagement on the Menorah Park Engagement Scale is defined as doing or commenting on something related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Constructive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome.
Change From Baseline to Treatment for Passive Engagement on the Menorah Park Engagement Scale
时间窗: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Passive Engagement on the Menorah Park Engagement Scale is defined as listening or watching something related to the target activity.During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Higher scores represent a better outcome..
Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale
时间窗: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Other Engagement on the Menorah Park Engagement Scale is defined as doing, commenting, listening, or watching something NOT related to the target activity. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Other Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Change From Baseline to Treatment for Non Engagement on the Menorah Park Engagement Scale
时间窗: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Non-Engagement on the Menorah Park Engagement Scale is defined as sleeping and/or staring into space. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Non-Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
Change From Baseline to Treatment for Pleasure on the Menorah Park Engagement Scale
时间窗: Baseline (Month 1) and Treatment (Months 2, 3, and 4)
Pleasure on the Menorah Park Engagement Scale is defined as clearly observable laughing or smiling. During baseline, multiple observations of "standard" activities were observed and a single mean score was calculated for all sessions observed during that month. Then, again, during treatment, multiple treatment activity sessions were observed over the course of three months (Months 2, 3, and 4) and a single mean score was calculated. The minimum value for Pleasure is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.
次要结局
- Change From Baseline to Treatment on Dementia Related Quality of Life (DEMQOL)(Baseline (Month 1) and Post-Treatment (Month 4))
- Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)(Baseline (Month 1) and Post-Treatment (Month 4))
- Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)(Baseline (Month 1) and Post-Treatment (Month 4))
- Change From Baseline to Treatment on the Cohen Mansfield Agitation Inventory (CMAI)(Baseline (Month 1) and Post-Treatment (Month 4))