Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

Conditions
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Insomnia, Pain, Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
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* Behavioral: Healthy Habits
* Behavioral: Sleep Habits


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to either the a healthy habits group or a sleep habits group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Habits<br>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<br>* 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.<br>|
| Other: Sleep Habits<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Physical Function (short form) | 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' | 7-14 days before scheduled surgery | 
| PROMIS Physical Function (short form) | 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' | 7-14 days after hospital discharge | 
| PROMIS Physical Function (short form) | 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' | 7-14 days after completing the 8 week intervention period | 
| PROMIS Physical Function (short form) | 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' | 6 months after completing the intervention | 
| PROMIS Mobility | 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. | 7-14 days before scheduled surgery | 
| PROMIS Mobility | 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. | 7-14 days after hospital discharge | 
| PROMIS Mobility | 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. | 7-14 days after completing the 8 week intervention period | 
| PROMIS Mobility | 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. | 6 months after completing the intervention | 
| Short Physical Performance Battery (SPPB ) motor | 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. | 7-14 days before scheduled surgery | 
| Short Physical Performance Battery (SPPB ) motor | 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. | 7-14 days after hospital discharge | 
| Short Physical Performance Battery (SPPB ) motor | 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. | 7-14 days after completing the 8 week intervention period | 
| Short Physical Performance Battery (SPPB ) motor | 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. | 6 months after completing the intervention | 
| PROMIS Applied Cognitive Abilities | 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. | 7-14 days before scheduled surgery | 
| PROMIS Applied Cognitive Abilities | 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. | 7-14 days after hospital discharge | 
| PROMIS Applied Cognitive Abilities | 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. | 7-14 days after completing the 8 week intervention period | 
| PROMIS Applied Cognitive Abilities | 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. | 6 months after completing the intervention | 
| PROMIS Applied Cognitive Abilities- General Concerns | 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. | 7-14 days before scheduled surgery | 
| PROMIS Applied Cognitive Abilities- General Concerns | 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. | 7-14 days after hospital discharge | 
| PROMIS Applied Cognitive Abilities- General Concerns | 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. | 7-14 days after completing the 8 week intervention period | 
| PROMIS Applied Cognitive Abilities - General Concerns | 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. | 6 months after completing the intervention | 
| Tele-neuropsychology (T-NP) Battery | The T-NP 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. | 7-14 days before scheduled surgery | 
| Tele-neuropsychology (T-NP) Battery | The T-NP 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. | 7-14 days after hospital discharge | 
| Tele-neuropsychology (T-NP) Battery | The T-NP 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. | 7-14 days after completing the 8 week intervention period | 
| Tele-neuropsychology (T-NP) Battery | 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. | 6 months after completing the intervention | 
| Activities of Daily Living (ADLs) | 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 | 7-14 days before scheduled surgery | 
| Activities of Daily Living (ADLs) | 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 | 7-14 days after hospital discharge | 
| Activities of Daily Living (ADLs) | 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 | 7-14 days after completing the 8 week intervention period | 
| Activities of Daily Living (ADLs) | 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 | 6 months after completing the intervention | 
| Instrumental ADLs (IADL) scale | 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. | 7-14 days before scheduled surgery | 
| Instrumental ADLs (IADL) scale | 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. | 7-14 days after hospital discharge | 
| Instrumental ADLs (IADL) scale | 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. | 7-14 days after completing the 8 week intervention period and | 
| Instrumental ADLs (IADL) scale | 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. | 6 months after completing the intervention | 
| Sleep Diary | 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. | 7-14 days before scheduled surgery | 
| Sleep Diary | 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. | 7-14 days after hospital discharge | 
| Sleep Diary | 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. | During the 8 week intervention | 
| Sleep Diary | 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. | 7-14 days after completing the 8 week intervention period | 
| Sleep Diary | 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. | 6 months after completing the intervention | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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. | 7-14 days before scheduled surgery | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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. | 6 months after completing intervention | 
| Hip disability and osteoarthritis outcome score (HOOS) | 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. | 7-14 days before scheduled surgery | 
| Hip disability and osteoarthritis outcome score (HOOS) | 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. | 6 months after completing intervention | 
| StepWatch | A wearable device will measure physical activity over a seven day period. | 7-14 days before scheduled surgery | 
| StepWatch | A wearable device will measure physical activity over a seven day period. | 7-14 days after hospital discharge | 
| StepWatch | A wearable device will measure physical activity over a seven day period. | 7-14 days after completing the 8 week intervention period | 
| StepWatch | A wearable device will measure physical activity over a seven day period. | 6 months after completing the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroplasty, Hip Arthroplasty, Rehabilitation