Companion Dog Walking for ICU Survivor Health

NCT ID: NCT05820308

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Post Intensive Care Syndrome Depression Anxiety Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants will be randomly assigned and masked to their group assignment

Study Groups

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Intervention Group

Companion dog walking

Group Type EXPERIMENTAL

Companion Dog Walking

Intervention Type 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.

Attention Control Group

Educational resources about dog health

Group Type ACTIVE_COMPARATOR

Attention Control Group

Intervention Type BEHAVIORAL

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

Interventions

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Companion Dog Walking

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 Type BEHAVIORAL

Attention Control Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sigma Theta Tau International Honor Society of Nursing

OTHER

Sponsor Role collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lindsey Nelson, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Locations

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Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Francis Hospital

Colorado Springs, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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2094468

Identifier Type: -

Identifier Source: org_study_id

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