Companion Dog Walking for ICU Survivor Health

NCT05820308 | Completed

• 1 other identifier: 2094468
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Intensive Care Syndrome; Depression; Anxiety; Quality of Life

Keywords

Post Intensive Care Syndrome; ICU Survivors; Companion dog; Depression; Anxiety; Quality of life

Outcome Measures

Primary Outcomes (2)

• Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points

  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?

  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.

• 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.

  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.

  Acceptability will be assessed post-intervention after participants complete the 8-week study period.

Secondary Outcomes (4)

• 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).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Companion dog walking

Behavioral: Companion Dog Walking

Attention Control Group

ACTIVE COMPARATOR

Educational resources about dog health

Behavioral: Attention Control Group

Interventions

Companion Dog Walking BEHAVIORAL

Participants will be asked to walk their dog three times per week, for a minimum of 30 minutes each day of walking, over an 8-week period.

Intervention Group

Attention Control Group BEHAVIORAL

Participants will be asked to read educational materials on dog health once per week, over an 8-week period.

Attention Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• Sigma Theta Tau International Honor Society of Nursing: collaborator

Study Sites (2)

Penrose Hospital

Colorado Springs, Colorado, 80907, United States

Location

St. Francis Hospital

Colorado Springs, Colorado, 80923, United States

Location

MeSH Terms

Conditions

postintensive care syndrome; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Lindsey Nelson, MSN, RN

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned and masked to their group assignment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 19, 2023
• Study Start: May 15, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)