Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

NCT04269239 | Completed

• 1 other identifier: H - 45617 HealthyHab
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

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.

Conditions

Insomnia; Pain; Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Knee Arthroplasty; Hip Arthroplasty; Rehabilitation

Outcome Measures

Primary Outcomes (8)

• Insomnia Severity Index (ISI)

  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.

  7-14 days before scheduled surgery

• Insomnia Severity Index (ISI)

  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.

  7-14 days after hospital discharge

• Insomnia Severity Index (ISI)

  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.

  7-14 days after completing the 8 week intervention period

• Insomnia Severity Index (ISI)

  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.

  6 months after completing the intervention

• Wrist actigraphy

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

  7-14 days before scheduled surgery

• Wrist actigraphy

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

  7-14 days after hospital discharge

• Wrist actigraphy

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

  7-14 days after completing the 8 week intervention period

• Wrist actigraphy

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

  6 months after completing the intervention

Secondary Outcomes (45)

• PROMIS Physical Function (short form)

  7-14 days before scheduled surgery

• PROMIS Physical Function (short form)

  7-14 days after hospital discharge

• PROMIS Physical Function (short form)

  7-14 days after completing the 8 week intervention period

• PROMIS Physical Function (short form)

  6 months after completing the intervention

• PROMIS Mobility

  7-14 days before scheduled surgery

Other Outcomes (51)

• PROMIS Pain Intensity

  7-14 days before scheduled surgery

• PROMIS Pain Intensity

  7-14 days after hospital discharge

• PROMIS Pain Intensity

  7-14 days after completing the 8 week intervention period

Study Arms (2)

Healthy Habits

OTHER

This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.

Behavioral: Healthy Habits

Sleep Habits

OTHER

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.

Behavioral: Sleep Habits

Interventions

Healthy Habits BEHAVIORAL

Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.

Healthy Habits

Sleep Habits BEHAVIORAL

Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.

Sleep Habits

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (3)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

Kelsey Seybold Clinic

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain; Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Sleep

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sara Nowakowski, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be assigned to either the a healthy habits group or a sleep habits group.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: April 30, 2021
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)