Clinical trial NCT05820308: Companion Dog Walking for ICU Survivor Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Intensive Care Syndrome
Depression
Anxiety
Quality of Life
Keywords: Post Intensive Care Syndrome
ICU Survivors
Companion dog
Depression
Anxiety
Quality of life
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Sigma Theta Tau International Honor Society of Nursing
First posted: 2023-04-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points
timeFrame: 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.
measure: 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.
timeFrame: Acceptability will be assessed post-intervention after participants complete the 8-week study period.
Secondary outcomes:
measure: Change in Depression
timeFrame: 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).
measure: Change in Anxiety
timeFrame: 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).
measure: 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.
timeFrame: 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).
measure: Change in Serum Cortisol
timeFrame: 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).
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Penrose Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: St. Francis Hospital
state: Colorado
Study officials:
affiliation: University of Missouri, Kansas City
name: Lindsey Nelson, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References: