Development and Preliminary Evaluation of an App to Reduce Caregiver Stress and Burden Among Informal Caregivers of People Living With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 8-weeks
研究概览
简要总结
Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. The goal of our study is to test a newly developed app that focuses on providing stress management strategies for caregivers of people living with dementia.
详细描述
Caregivers of people living with dementia experience significant stress which can negatively affect their mental health. Psychological interventions that focus on building skills and providing strategies to improve their well-being have been shown to improve caregiver well-being. Although mobile applications (apps) are available for caregivers of people living with dementia, existing apps do not adequately address the stress and mental health needs experienced by caregivers of people living with dementia. In addition, there is a paucity of mobile app interventions that provide practical stress management strategies for caregivers. The goal of the study is to conduct an evaluation of a novel app (UR Caregiver) that focuses on providing stress management strategies for caregivers of people living with dementia. The app utilizes cognitive behavioural principles and is consistent with models of stress and coping. Caregivers of people living with dementia will be recruited and randomly assigned to three groups: 1) UR Caregiver; 2) active control; and 3) non-app using control. Participants in the app-using groups will be asked to use the app over an 8-week period. Stress, burden, and mental health will be assessed before, after the 8-week period, and at a follow-up period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Given the demands that caregivers of people living with dementia face daily, the creation and evaluation of an app that aims to provide stress-management strategies has the potential of improving the quality of life of caregivers of people living with dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •caregivers providing informal and unpaid care (e.g., spouses, children, relatives) for a person living with dementia
- •providing primary care (i.e., most of the care or equally shares the care with another individual such as a mother or sibling) for the person living with dementia
- •own a smartphone/tablet (i.e., can access either IOS or Android platforms).
排除标准
- •1) Currently using an app for caregiver stress/burden
研究组 & 干预措施
Non-app using control
Participants in this group will not be using any apps in the study.
UR Caregiver group
Participants will be asked to use the UR Caregiver app daily (e.g., at least 15 minutes/day) for 8 weeks and complete and practice one module per week. On the eighth week, participants will be asked to review one of the past modules of their choice.
干预措施: UR Caregiver (Other)
Active control
Participants will be asked to use the app daily (e.g., at least 15 minutes/day) for an 8-week period.
干预措施: CLEAR Dementia Care (Other)
结局指标
主要结局
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 8-weeks
时间窗: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up
时间窗: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress
Change from after the 8-week period in the Perceived Stress Scale-10 (PSS-10) total scores at a 4-week follow-up
时间窗: The PSS-10 will be administered immediately after the 8-week period and at a 4-week follow-up period
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload over the past month. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress
Change from baseline in the BSFC-S total scores at a 4-week follow-up
时间窗: The BSFC-S will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up
Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden
Change from after the 8-week period in the BSFC-S total scores at a 4-week follow-up
时间窗: The BSFC-S will be administered immediately after the 8-week period and at a 4-week follow-up period
Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden
Change from after the 8-week period in the PHQ-9 total scores at a 4-week follow-up
时间窗: The PHQ-9 will be administered immediately after the 8-week period and at a 4-week follow-up period
The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.
Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) total scores at 8-weeks
时间窗: The GAD-7 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)
The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.
Change from baseline in the GAD-7 total scores at a 4-week follow-up
时间窗: The GAD-7 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period
The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.
Change from baseline in the Burden Scale for Family Caregivers-Short Version (BSFC-S) total scores at 8-weeks
时间窗: The BSFC-S will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)
Subjective caregiver burden will be assessed using the BSFC-S. The BSFC-S is a 10-item scale developed to assess subjective burden. The BSFC-S was derived from the original 28-item scale. Each item is rated on a scale from 0 (Strongly disagree) to 3 (Strongly agree). Responses are summed with total scores ranging from 0 to 30 points with higher scores indicating greater caregiver burden
Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) total scores at 8-weeks
时间窗: The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period)
The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.
Change from baseline in the PHQ-9 total scores at a 4-week follow-up
时间窗: The PHQ-9 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow-up period
The PHQ-9 is a 9-item self-report instrument widely used to assess for the presence and frequency of depressive symptoms over the last two weeks. Each of the nine items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 27) is calculated with increasing scores indicating greater depressive symptoms.
Change from after the 8-week period in the GAD-7 total scores at a 4-week follow-up
时间窗: The GAD-7 will be administered immediately after the 8-week period and at a 4-week follow-up period
The GAD-7 is a 7-item self-report instrument widely used to assess for anxiety symptoms. Each of the seven items is rated on a Likert scale ranging from 0 (Not at all) to 3 (Nearly every day). A total score (e.g., from 0 to 21) is calculated with increasing scores indicating greater anxiety symptoms.
次要结局
- Change from baseline in the Multidimensional Scale for Perceived Social Support (MSPSS) total scores at 8-weeks(The MSPSS will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period))
- Change from baseline in the Brief-COPE subscale scores at a 4-week follow-up(The Brief-COPE will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period)
- Change from baseline in the MSPSS total scores at a 4-week follow-up(The MSPSS will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period)
- Change from after the 8-week period in the MSPSS total scores at a 4-week follow-up(The MSPSS will be administered immediately after the 8-week period and at a 4-week follow-up period)
- Change from baseline in the Caregiving Self-Efficacy Scale (CSES-8) total scores at 8-weeks(The CSES-8 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period))
- Change from baseline in the CSES-8 total scores at a 4-week follow-up(The CSES-8 will be administered at baseline (i.e., prior to starting the study) and at a 4-week follow up period)
- Change from after the 8-week period in the CSES-8 total scores at a 4-week follow-up(The CSES-8 will be administered immediately after the 8-week period and at a 4-week follow-up period)
- Change from baseline in the Brief-Coping Orientation to Problems Experienced Inventory (Brief-COPE) subscale scores at 8-weeks(The Brief-COPE will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 8-week period))
- Change from after the 8-week period in the Brief-COPE subscale scores at a 4-week follow-up(The Brief-COPE will be administered immediately after the 8-week period and at a 4-week follow-up period)