跳至主要内容
临床试验/NCT05516134
NCT05516134已完成不适用

All About Me: An Intervention to Ease the Transition to Long-term Care, Build Community, and Improve Quality of Care for Persons With Dementia

Hopeful Aging1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年4月18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
发起方
入组人数
51
试验地点
1
主要终点
Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale

研究概览

简要总结

This Phase I study will involve initial development and evaluation of an innovative cross-platform software app called All About Me (AAM), which will consist of Serious Digital Health Games (SDHGs) for PWD. The AAM app will assist staff in providing person-centered care and enable residents to improve relationships with one another and with staff, thereby promoting a sense of community. This Phase I study has three Specific Aims: (1) Develop an Alpha version of the AAM App, (2) Examine acceptability of and satisfaction with the AAM App, and (3) Examine the impact of the Resident Game Bundle / Survey Says Game on engagement/affect.

详细描述

Study Design: The study will utilize a quasi-experimental pre-post design.

Sample:

PWD: Twenty-four PWD will take part in the study, including 12 ALF residents and 12 living in a NH.

Family Members: Twenty-four family members will also take part in the study-i.e., one for each PWD. In some cases, the "family member" may be a friend or legally authorized representative.

Staff Members: Twelve LTC staff members will take part in the quasi-experiment-five at the ALF and five at the NH.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •must be 60+ years old
  • •must speak and read English
  • •must have a clinical diagnosis of dementia (of any type)
  • •must score at least eight on the Mini-Mental Status Examination (MMSE)

排除标准

  • •shows signs of rapid physical / cognitive decline over the past six months, as indicated by medical records

研究组 & 干预措施

Treatment

Experimental

Participants who receive the intervention (all)

干预措施: SAFE at Home (Behavioral)

结局指标

主要结局

Change From Baseline to Treatment for Constructive Engagement on the Menorah Park Engagement Scale

时间窗: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Treatment (Weeks 5-10)

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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean was calculated. The minimum value for Passive Engagement is zero (0) and the maximum score is two (2). Lower scores represent a better outcome.

Change From Baseline to Treatment for Other Engagement on the Menorah Park Engagement Scale

时间窗: Baseline (Weeks 1-4) and Treatment (Weeks 5-10)

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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Treatment (Weeks 5-10)

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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Treatment (Weeks 5-10)

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 mean was calculated. Then, again, during treatment, multiple activities were observed and a mean 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 (Weeks 1-4) and Post-Treatment (Week 11))
  • Change From Baseline to Treatment on the Neuropsychiatric Inventory-Nursing Home (NPI-NH), Frequency x Severity Score (FxS)(Baseline (Weeks 1-4) and Post-Treatment (Week 11))
  • Change From Baseline to Treatment on the Geriatric Depression Scale-Short Form (GDS-SF)(Baseline (Weeks 1-4) and Post-Treatment (Week 11))
  • Satisfaction With the App(Treatment (Weeks 5-11))

研究者

发起方
Hopeful Aging
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验