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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 after completing the 8 week intervention period

Awards & highlights

No Placebo-Only Group

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

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I am 55 or older and planning to have hip or knee replacement surgery.

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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:

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I have not treated sleep disorders like narcolepsy or sleep apnea.

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I have not had a severe mental health crisis or hospitalization in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-14 days after completing the 8 week intervention period

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met