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Healthy Habits + Sleep Habits for Hospitalized Older Adults to Optimize Rehabilitation (HH Trial)

N/A
Recruiting
Led By Sara Nowakowski, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients (ages 55+) planning on having a hip or knee arthroplasty.
Score ≥10 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days after completing the 8 week intervention period
Awards & highlights

HH Trial Summary

This trial will study how well two different types ofbehavioral interventions work to help patients recovering fromorthopedic surgery improve their functional health. One groupwill focus on healthy habits and the other on healthy sleephabits.

Who is the study for?
This trial is for adults aged 40 and above who are recovering from hip or knee surgery, have insomnia according to DSM-5 criteria, can communicate effectively, and will attend medical rehab post-discharge. Excluded are those with severe mental health issues, substance abuse, certain cognitive impairments, or untreated sleep disorders like narcolepsy.Check my eligibility
What is being tested?
The study tests two behavioral interventions: one focuses on general healthy habits while the other targets healthy sleep habits. Participants will be randomly assigned to either group and undergo physical and cognitive assessments during their recovery from orthopedic surgery.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, side effects may include discomfort or stress related to changing daily routines or adopting new habits but no medicinal side effects are expected.

HH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 55 or older and planning to have hip or knee replacement surgery.
Select...
I have significant trouble sleeping, as shown by my sleep test scores.

HH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days after completing the 8 week intervention period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days after completing the 8 week intervention period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index (ISI)
Actigraphy
Secondary outcome measures
Activities of Daily Living (ADLs)
Hip disability and osteoarthritis outcome score (HOOS)
Instrumental ADLs (IADL) scale
+10 more
Other outcome measures
Medication Monitoring Form
PROMIS Ability to Participate in Social Roles and Activity
PROMIS Emotional Distress-Depressesion
+12 more

HH Trial Design

2Treatment groups
Experimental Treatment
Group I: Sleep HabitsExperimental Treatment1 Intervention
This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.
Group II: Healthy HabitsExperimental Treatment1 Intervention
This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,088 Total Patients Enrolled
3 Trials studying Osteoarthritis
323 Patients Enrolled for Osteoarthritis
Sara Nowakowski, PhDPrincipal InvestigatorBaylor College of Medicine

Media Library

Osteoarthritis Research Study Groups: Sleep Habits, Healthy Habits
Osteoarthritis Clinical Trial 2023: Sleep Habits Highlights & Side Effects. Trial Name: NCT04269239 — N/A
Sleep Habits 2023 Treatment Timeline for Medical Study. Trial Name: NCT04269239 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the aims of this research?

"The goal of this trial is to improve patient outcomes as measured by the Insomnia Severity Index (ISI). Secondary measures of success include the PROMIS Applied Cognitive Abilities - General Concerns scale, Activities of Daily Living (ADLs), and PROMIS Mobility."

Answered by AI

Are individuals still able to sign up for this clinical trial?

"The study, which is currently looking for participants, was first posted on clinicaltrials.gov on April 30th, 2021 and was last edited October 25th, 2022."

Answered by AI

How many volunteers are needed for this experiment?

"Yes, that is accurate. The clinical trial in question is still underway, as can be seen from the dates on the website. It was first posted on April 30th, 2021 and updated October 25th, 2022. There are 124 slots which need to be filled at 2 locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas Medical Branch
Kelsey Seybold Clinic
Baylor College of Medicine Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

What questions have other patients asked about this trial?

Are there any overnight stays?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I want to know what a good night's sleep feels like. I have always had a hard time getting a good nights rest. I also have bad dreams at night.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Kelsey Seybold Clinic: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Sara Nowakowski 2021. "Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04269239.
All > Pain Management > Osteoarthritis Knee
~12 spots leftby Aug 2024
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