Post Intensive Care SyndromePOOCHNCT05820308
Companion Dog Walking for ICU Survivor Health
A study testing Companion Dog Walking in people with Post Intensive Care Syndrome and Depression, run by University of Missouri, Kansas City at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome, Depression, Anxiety
- What is being tested?
- Companion Dog Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penrose Hospital
Colorado Springs, Colorado, 80907
St. Francis Hospital
Colorado Springs, Colorado, 80923
About this study
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
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:
Read more
- 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
- Being tested
- Companion Dog Walking, Attention Control Group
- Keywords
- Post Intensive Care Syndrome, ICU Survivors, Companion dog, Depression, Anxiety, Quality of life
- Medical subject headings
- postintensive care syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Companion Dog WalkingBehavioural
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 GroupBehavioural
Participants will be asked to read educational materials on dog health once per week, over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Companion dog walking Receives: Behavioral: Companion Dog Walking |
| Attention Control Group | Active comparator | Educational resources about dog health Receives: Behavioral: Attention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points
Data will be collected to answer the following questions:
- To what extent does the recruitment procedure produce study participants?
- How many participants met inclusion and exclusion criteria?
- What are the obstacles to recruitment?
- What was the attrition rate of participants?
- To what extent was fidelity of the intervention maintained by participants?
- To what extent were measurements completed?
- What was the extent and patterns of missing data?
Measured: 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.
Measured: Acceptability will be assessed post-intervention after participants complete the 8-week study period.
Secondary outcomes (4)
Change in Depression
The Center for Epidemiologic Studies Depression Scale is a 20-item self-report tool that assesses intensity of depression using a 4-point Likert scale. Lower scores indicate milder levels of depression while higher scores indicate more severe depression (potential score 0-60). Clinically meaningful depression is represented by a score of 16 or greater.
Measured: 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
The Spielberger State Trait Anxiety Inventory is a 40-item self-report assessment tool using a 4-point Likert scale that assesses both trait and state anxiety. The higher a participant's score (potential score 20-80 on each subscale) the higher the level of anxiety. No/low anxiety = 20-37 points; moderate anxiety= 38-44 points; and high anxiety=45-80 points, with a cut-off point of 39 indicting clinically significant symptoms of anxiety.
Measured: 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.
The Short Form 36 is a 36-item self-report questionnaire using various ranking questions to measure health related quality of life. The Shot Form 36 examines eight dimensions of health related quality of life (physical functioning, physical and emotional limitations, social functioning, bodily pain, general and mental health). The higher the score (max score =100) the better the health and wellbeing, the lower the score (minimum score=0) the poorer the health and wellbeing.
Measured: 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
Peripheral venous blood samples will be obtained from participants or analysis at a laboratory.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 May 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing
- Responsible party
- Sponsor
- Investigators
- Lindsey Nelson, MSN, RN, Principal investigator, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820308
- Sponsor's protocol ID
- 2094468
- Acronym
- POOCH
- Status last verified
- May 2024
- First submitted
- 28 Mar 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05820308
- Acronym / sponsor ID
- POOCH / 2094468
- Conditions
- Post Intensive Care Syndrome, Depression, Anxiety, Quality of Life
- Keywords
- Post Intensive Care Syndrome, ICU Survivors, Companion dog, Depression, Anxiety, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Companion Dog WalkingCompanion dog walking |
| Attention Control Group | Active comparator | Behavioral: Attention Control GroupEducational resources about dog health |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Companion Dog WalkingParticipants 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. | Behavioural | Intervention Group |
| Attention Control GroupParticipants will be asked to read educational materials on dog health once per week, over an 8-week period. | Behavioural | Attention Control Group |
Primary outcome
Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points
Time frame: 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.
Time frame: 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.
4 secondary outcomes
Change in Depression
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Nelson, MSN, RN principal investigator
University of Missouri, Kansas City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Companion Dog Walking in people with Post Intensive Care Syndrome and Depression, run by University of Missouri, Kansas City at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility as assessed by recruitment results, attrition rates, intervention fidelity, and missing data points (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.