Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Not Applicable

Recruiting

• Conditions: Pain; Osteoarthritis, Knee; Insomnia; Osteoarthritis, Hip
• Interventions: Behavioral: Healthy Habits; Behavioral: Sleep Habits

• Registration Number: NCT04269239
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Study Start: 2021-04-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-08-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Habits	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.
Sleep Habits	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.

Primary Outcome Measures

Name	Time	Method
Wrist actigraphy	6 months after completing the intervention	A wearable device will be used to measure participant sleep over seven days.
Insomnia Severity Index (ISI)	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 Outcome Measures

Name	Time	Method
PROMIS Mobility	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.
PROMIS Applied Cognitive Abilities- General Concerns	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	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.
Instrumental ADLs (IADL) scale	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.
Hip disability and osteoarthritis outcome score (HOOS)	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	6 months after completing the intervention	A wearable device will measure physical activity over a seven day period.
PROMIS Physical Function (short form)	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 Applied Cognitive Abilities	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.
Tele-neuropsychology (T-NP) Battery	6 months after completing the intervention	The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.
Knee injury and osteoarthritis outcome score (KOOS)	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.
Short Physical Performance Battery (SPPB ) motor	6 months after completing the intervention	The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.
Activities of Daily Living (ADLs)	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"
Sleep Diary	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.

Trial Locations

Locations (3)

Kelsey Seybold Clinic; 🇺🇸 Houston, Texas, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Baylor College of Medicine Medical Center; 🇺🇸 Houston, Texas, United States