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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).
Must not have
Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days before scheduled surgery
Awards & highlights

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not treated sleep disorders like narcolepsy or sleep apnea.
Select...
I have not had a severe mental health crisis or hospitalization in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days before scheduled surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days before scheduled surgery for reporting.

Treatment Details

Study Objectives

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

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
1,018 Previous Clinical Trials
6,031,305 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
~29 spots leftby Sep 2025
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