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NCT04269239 | RECRUITING | Insomnia

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Sponsor:

Baylor College of Medicine

Information provided by (Responsible Party):

Sara Nowakowski

Brief Summary:

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Condition or disease

Insomnia

Pain

Osteoarthritis, Knee

Osteoarthritis, Hip

Intervention/treatment

Healthy Habits

Sleep Habits

Phase

NA

Detailed Description:

Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

Study Type : INTERVENTIONAL
Estimated Enrollment : 124 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Actual Study Start Date : 2021-04-30
Estimated Primary Completion Date : 2024-08-31
Estimated Study Completion Date : 2024-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty.
  • 2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
  • 3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
  • 4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
  • 5. Referral and attendance of medical rehabilitation post-discharge.
Exclusion Criteria
  • 1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
  • 2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).
  • 3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
  • 4. Cognitive impairment defined as \<20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of \<24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Location Details

NCT04269239

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Locations

RECRUITING

United States, Texas

University of Texas Medical Branch

Galveston, Texas, United States, 77555

RECRUITING

United States, Texas

Baylor College of Medicine Medical Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Kelsey Seybold Clinic

Houston, Texas, United States, 77054