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Clinical Trials/NCT04269239
NCT04269239
Completed
Not Applicable

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Baylor College of Medicine3 sites in 1 country73 target enrollmentApril 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Baylor College of Medicine
Enrollment
73
Locations
3
Primary Endpoint
Wrist actigraphy
Status
Completed
Last Updated
8 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2021
End Date
November 30, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Nowakowski

Associate Professor

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty.
  • The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
  • Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
  • Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
  • Referral and attendance of medical rehabilitation post-discharge.

Exclusion Criteria

  • Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
  • 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).
  • Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
  • 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.

Outcomes

Primary Outcomes

Wrist actigraphy

Time Frame: 6 months after completing the intervention

A wearable device will be used to measure participant sleep over seven days.

Insomnia Severity Index (ISI)

Time Frame: 6 months after completing the intervention

ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.

Secondary Outcomes

  • PROMIS Mobility(6 months after completing the intervention)
  • PROMIS Applied Cognitive Abilities- General Concerns(7-14 days after completing the 8 week intervention period)
  • PROMIS Applied Cognitive Abilities - General Concerns(6 months after completing the intervention)
  • Instrumental ADLs (IADL) scale(6 months after completing the intervention)
  • Hip disability and osteoarthritis outcome score (HOOS)(6 months after completing intervention)
  • StepWatch(6 months after completing the intervention)
  • PROMIS Physical Function (short form)(6 months after completing the intervention)
  • PROMIS Applied Cognitive Abilities(6 months after completing the intervention)
  • Tele-neuropsychology (T-NP) Battery(6 months after completing the intervention)
  • Knee injury and osteoarthritis outcome score (KOOS)(6 months after completing intervention)
  • Short Physical Performance Battery (SPPB ) motor(6 months after completing the intervention)
  • Activities of Daily Living (ADLs)(6 months after completing the intervention)
  • Sleep Diary(6 months after completing the intervention)

Study Sites (3)

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