Feasibility and Acceptability of a Randomized Controlled Trial Comparing a Companion Dog-Walking Intervention to an Attention Control Education Intervention on the Psychological Health of Adult Intensive Care Unit Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points
研究概览
简要总结
The goal of this clinical trial is to determine the feasibility and acceptability of a randomized controlled trial comparing a pet dog walking intervention to an attention control education intervention in adult intensive care unit survivors.
The main question[s] it aims to answer are:
- What is the feasibility of a pet dog-walking intervention compared to an attention control education intervention on depression, anxiety, cortisol, and quality of life for adult ICU survivors.
- What is the acceptability of a pet dog-walking intervention compared to an attention control education intervention on depression, anxiety, cortisol, and quality of life for adult ICU survivors.
The secondary question[s] it aims to answer are:
- What are the differences in depression, anxiety, serum cortisol, and quality of life between and within a companion dog walking intervention compared to an attention control education intervention for ICU survivors?
Participants in the intervention group will be asked to:
- Participate in dog walking with their pet dog at least three times per week, for at least 10 minutes each walk, for 8-weeks.
- Wear an activity monitor and record their dog walks in a diary.
- Complete surveys to measure depression, anxiety, and quality of life at the start of the study, after week 4, and after week 8.
- Have blood drawn to measure cortisol levels at the start of the study, after week 4, and after week 8.
Participants in the control group will be asked to:
- Read educational materials about their pet dog's health once every week (education materials are provided by the researchers).
- Wear an activity monitor and record when they read their education materials in a diary.
- Complete surveys to measure depression, anxiety, and quality of life at the start of the study, after week 4, and after week 8.
- Have blood drawn to measure cortisol levels at the start of the study, after week 4, and after week 8.
Participants will be assigned to an intervention group or a control group to see if there are differences in depression, anxiety, serum cortisol, and quality of life.
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
- Single (Participant)
盲法说明
Participants will be randomly assigned and masked to their group assignment
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
- •Adult (≥18 years)
- •ICU survivors (spent ≥24 hours in the ICU)
- •Will be discharged directly home from hospital.
- •Able to speak, read, and understand English
- •Physically capable of dog walking
- •Individuals who have symptoms of depression and/or anxiety
- •Individuals who own a companion dog and walk their dog <10 minutes/week
- •Participants scoring ≤ 20 seconds on the TUG Test
排除标准
- •Individuals at high risk for suicide
- •Individuals with severe depression or anxiety
- •Individuals who recently started treatment for depression and/or anxiety
- •Individuals with cognitive impairment
- •Dog walking is deemed unsafe with and for the dog
- •Medical Provider authorization is indicated but not provided
- •Individuals who live outside a 45-mile radius of Colorado Springs.
研究组 & 干预措施
Intervention Group
Companion dog walking
干预措施: Companion Dog Walking (Behavioral)
Attention Control Group
Educational resources about dog health
干预措施: Attention Control Group (Behavioral)
结局指标
主要结局
Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points
时间窗: Feasibility data will be collected and analyzed from the time identifying, screening, and recruiting eligible participants begins to the time the final participant completes the study; no more than 12 months.
Data will be collected to answer the following questions: 1. To what extent does the recruitment procedure produce study participants? 2. How many participants met inclusion and exclusion criteria? 3. What are the obstacles to recruitment? 4. What was the attrition rate of participants? 5. To what extent was fidelity of the intervention maintained by participants? 6. To what extent were measurements completed? 7. What was the extent and patterns of missing data?
Study Acceptability as assessed by participant responses to survey questions regarding the amount of time spent in the study, the measurement tools used, the masking procedure, and the intervention.
时间窗: Acceptability will be assessed post-intervention after participants complete the 8-week study period.
Participants will complete an exit survey and will be asked to report on: (1) the acceptability of the time spent in the study and per session, (2) the acceptability of completing the measurement tools, (3) the acceptability of the masking procedure, (4) the acceptability of the intervention, (5) if they intend to continue the intervention after the end of the study, and (6) to report any suggestions for improvement they have.
次要结局
- Change in Depression(Depression will be measured at baseline, half way through the intervention (at the end of week 4), and post intervention (at the end of week 8).)
- Change in Anxiety(Anxiety will be measured at baseline, half way through the intervention (at the end of week 4), and post intervention (at the end of week 8).)
- Change in Quality of Life as assessed by health related quality of life indicators including physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health.(Quality of life will be measured at baseline, half way through the intervention (at the end of week 4), and post intervention (at the end of week 8).)
- Change in Serum Cortisol(Serum Cortisol will be measured at baseline, half way through the intervention (at the end of week 4), and post intervention (at the end of week 8).)