Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 2023

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), in-hospital, post-hospital, post-intervention and at a 6 month follow-up visit.

Interventions

  • Behavioral: Healthy Habits
    • 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.
  • Behavioral: Sleep Habits
    • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Insomnia Severity Index (ISI)
    • Time Frame: 7-14 days before scheduled surgery
    • 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 ≥ 10 is optimal to detect clinical levels of insomnia.
  • Insomnia Severity Index (ISI)
    • Time Frame: 7-14 days after hospital discharge
    • 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 ≥ 10 is optimal to detect clinical levels of insomnia.
  • Insomnia Severity Index (ISI)
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • 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 ≥ 10 is optimal to detect clinical levels of insomnia.
  • 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 ≥ 10 is optimal to detect clinical levels of insomnia.
  • Wrist actigraphy
    • Time Frame: 7-14 days before scheduled surgery
    • A wearable device will be used to measure participant sleep over seven days.
  • Wrist actigraphy
    • Time Frame: 7-14 days after hospital discharge
    • A wearable device will be used to measure participant sleep over seven days.
  • Wrist actigraphy
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • A wearable device will be used to measure participant sleep over seven days.
  • Wrist actigraphy
    • Time Frame: 6 months after completing the intervention
    • A wearable device will be used to measure participant sleep over seven days.

Secondary Measures

  • PROMIS Physical Function (short form)
    • Time Frame: 7-14 days before scheduled surgery
    • The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank ‘from not at all’ to ‘cannot do’ how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from ‘without any difficulty’ to ‘unable to do’
  • PROMIS Physical Function (short form)
    • Time Frame: 7-14 days after hospital discharge
    • The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank ‘from not at all’ to ‘cannot do’ how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from ‘without any difficulty’ to ‘unable to do’
  • PROMIS Physical Function (short form)
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank ‘from not at all’ to ‘cannot do’ how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from ‘without any difficulty’ to ‘unable to do’
  • PROMIS Physical Function (short form)
    • Time Frame: 6 months after completing the intervention
    • The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank ‘from not at all’ to ‘cannot do’ how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from ‘without any difficulty’ to ‘unable to do’
  • PROMIS Mobility
    • Time Frame: 7-14 days before scheduled surgery
    • The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from ‘without any difficulty’ to ‘unable to do’ about their ability to perform various physical activities.
  • PROMIS Mobility
    • Time Frame: 7-14 days after hospital discharge
    • The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from ‘without any difficulty’ to ‘unable to do’ about their ability to perform various physical activities.
  • PROMIS Mobility
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from ‘without any difficulty’ to ‘unable to do’ about their ability to perform various physical activities.
  • PROMIS Mobility
    • Time Frame: 6 months after completing the intervention
    • The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from ‘without any difficulty’ to ‘unable to do’ about their ability to perform various physical activities.
  • NIH Toolbox Motor Tests
    • Time Frame: 7-14 days before scheduled surgery
    • Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).
  • NIH Toolbox Motor Tests
    • Time Frame: 7-14 days after hospital discharge
    • Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).
  • NIH Toolbox Motor Tests
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).
  • NIH Toolbox Motor Tests
    • Time Frame: 6 months after completing the intervention
    • Motor tests include 9-hole Pegboard (dexterity), Grip (strength), Standing (balance), 4-Meter Walk (gait speed), and 2-Minute Walk (endurance).
  • PROMIS Applied Cognitive Abilities
    • Time Frame: 7-14 days before scheduled surgery
    • The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from ‘not at all’ to ‘very much’ their perceived cognitive performance over the past seven days.
  • PROMIS Applied Cognitive Abilities
    • Time Frame: 7-14 days after hospital discharge
    • The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from ‘not at all’ to ‘very much’ their perceived cognitive performance over the past seven days.
  • PROMIS Applied Cognitive Abilities
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from ‘not at all’ to ‘very much’ their perceived cognitive performance over the past seven days.
  • PROMIS Applied Cognitive Abilities
    • Time Frame: 6 months after completing the intervention
    • The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from ‘not at all’ to ‘very much’ their perceived cognitive performance over the past seven days.
  • PROMIS Applied Cognitive Abilities – General Concerns
    • Time Frame: 7-14 days before scheduled surgery
    • The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from ‘never’ to ‘very often’ the incidence of perceived cognitive impairment over the past seven days.
  • PROMIS Applied Cognitive Abilities – General Concerns
    • Time Frame: 7-14 days after hospital discharge
    • The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from ‘never’ to ‘very often’ the incidence of perceived cognitive impairment over the past seven days.
  • PROMIS Applied Cognitive Abilities – General Concerns
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from ‘never’ to ‘very often’ the incidence of perceived cognitive impairment over the past seven days.
  • PROMIS Applied Cognitive Abilities – General Concerns
    • Time Frame: 6 months after completing the intervention
    • The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from ‘never’ to ‘very often’ the incidence of perceived cognitive impairment over the past seven days.
  • NIH Tool Box Cognition Tests
    • Time Frame: 7-14 days before scheduled surgery
    • NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.
  • NIH Tool Box Cognition Tests
    • Time Frame: 7-14 days after hospital discharge
    • NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.
  • NIH Tool Box Cognition Tests
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.
  • NIH Tool Box Cognition Tests
    • Time Frame: 6 months after completing the intervention
    • NIH Tool Box Cognition Tests are objective assessments of cognitive performance. Cognition tests include Picture (vocabulary), Flanker Inhibitory (control & attention), List Sorting (working memory), Dimensional Change Card Sort (executive function), Pattern Comparison (processing speed), Picture Sequence (memory),and Oral Reading (recognition). Cognition tests will be scored and combined to create a composite score.
  • Activities of Daily Living (ADLs)
    • Time Frame: 7-14 days before scheduled surgery
    • The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) – questions are answered as “need help” or “don’t need help”
  • Activities of Daily Living (ADLs)
    • Time Frame: 7-14 days after hospital discharge
    • The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) – questions are answered as “need help” or “don’t need help”
  • Activities of Daily Living (ADLs)
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) – questions are answered as “need help” or “don’t need help”
  • Activities of Daily Living (ADLs)
    • Time Frame: 6 months after completing the intervention
    • The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) – questions are answered as “need help” or “don’t need help”
  • Instrumental ADLs (IADL) scale
    • Time Frame: 7-14 days before scheduled surgery
    • The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a “yes” or “no” format.
  • Instrumental ADLs (IADL) scale
    • Time Frame: 7-14 days after hospital discharge
    • The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a “yes” or “no” format.
  • Instrumental ADLs (IADL) scale
    • Time Frame: 7-14 days after completing the 8 week intervention period and
    • The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a “yes” or “no” format.
  • Instrumental ADLs (IADL) scale
    • Time Frame: 6 months after completing the intervention
    • The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a “yes” or “no” format.
  • Sleep Diary
    • Time Frame: 7-14 days before scheduled surgery
    • The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
  • Sleep Diary
    • Time Frame: 7-14 days after hospital discharge
    • The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
  • Sleep Diary
    • Time Frame: During the 8 week intervention
    • The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
  • Sleep Diary
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
  • Sleep Diary
    • Time Frame: 6 months after completing the intervention
    • The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.
  • Knee injury and osteoarthritis outcome score (KOOS)
    • Time Frame: 7-14 days before scheduled surgery
    • This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
  • Knee injury and osteoarthritis outcome score (KOOS)
    • Time Frame: 6 months after completing intervention
    • This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
  • Hip disability and osteoarthritis outcome score (HOOS)
    • Time Frame: 7-14 days before scheduled surgery
    • This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
  • Hip disability and osteoarthritis outcome score (HOOS)
    • Time Frame: 6 months after completing intervention
    • This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.
  • StepWatch
    • Time Frame: 7-14 days before scheduled surgery
    • A wearable device will measure physical activity over a seven day period.
  • StepWatch
    • Time Frame: 7-14 days after hospital discharge
    • A wearable device will measure physical activity over a seven day period.
  • StepWatch
    • Time Frame: 7-14 days after completing the 8 week intervention period
    • A wearable device will measure physical activity over a seven day period.
  • StepWatch
    • Time Frame: 6 months after completing the intervention
    • A wearable device will measure physical activity over a seven day period.

Participating in This Clinical Trial

Inclusion Criteria

1. Patients (ages 55+) 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 ≥10 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.

5. Must live within 30 miles of recruiting site.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sara Nowakowski, Associate Professor – Baylor College of Medicine
  • Overall Official(s)
    • Sara Nowakowski, PhD, Principal Investigator, Baylor College of Medicine
  • Overall Contact(s)
    • Sara Nowakowski, PhD, 713-791-1414, sara.nowakowski@bcm.edu

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