Clinical trial NCT04269239: Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Official title: Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Pain
Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Knee Arthroplasty
Hip Arthroplasty
Rehabilitation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 124
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either the a healthy habits group or a sleep habits group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 7-14 days before scheduled surgery
measure: Insomnia Severity Index (ISI)
timeFrame: 7-14 days after hospital discharge
measure: Insomnia Severity Index (ISI)
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Insomnia Severity Index (ISI)
timeFrame: 6 months after completing the intervention
measure: Wrist actigraphy
timeFrame: 7-14 days before scheduled surgery
measure: Wrist actigraphy
timeFrame: 7-14 days after hospital discharge
measure: Wrist actigraphy
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Wrist actigraphy
timeFrame: 6 months after completing the intervention
Secondary outcomes:
measure: PROMIS Physical Function (short form)
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Physical Function (short form)
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Physical Function (short form)
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Physical Function (short form)
timeFrame: 6 months after completing the intervention
measure: PROMIS Mobility
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Mobility
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Mobility
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Mobility
timeFrame: 6 months after completing the intervention
measure: Short Physical Performance Battery (SPPB ) motor
timeFrame: 7-14 days before scheduled surgery
measure: Short Physical Performance Battery (SPPB ) motor
timeFrame: 7-14 days after hospital discharge
measure: Short Physical Performance Battery (SPPB ) motor
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Short Physical Performance Battery (SPPB ) motor
timeFrame: 6 months after completing the intervention
measure: PROMIS Applied Cognitive Abilities
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Applied Cognitive Abilities
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Applied Cognitive Abilities
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Applied Cognitive Abilities
timeFrame: 6 months after completing the intervention
measure: PROMIS Applied Cognitive Abilities- General Concerns
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Applied Cognitive Abilities- General Concerns
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Applied Cognitive Abilities- General Concerns
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Applied Cognitive Abilities - General Concerns
timeFrame: 6 months after completing the intervention
measure: Tele-neuropsychology (T-NP) Battery
timeFrame: 7-14 days before scheduled surgery
measure: Tele-neuropsychology (T-NP) Battery
timeFrame: 7-14 days after hospital discharge
measure: Tele-neuropsychology (T-NP) Battery
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Tele-neuropsychology (T-NP) Battery
timeFrame: 6 months after completing the intervention
measure: Activities of Daily Living (ADLs)
timeFrame: 7-14 days before scheduled surgery
measure: Activities of Daily Living (ADLs)
timeFrame: 7-14 days after hospital discharge
measure: Activities of Daily Living (ADLs)
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Activities of Daily Living (ADLs)
timeFrame: 6 months after completing the intervention
measure: Instrumental ADLs (IADL) scale
timeFrame: 7-14 days before scheduled surgery
measure: Instrumental ADLs (IADL) scale
timeFrame: 7-14 days after hospital discharge
measure: Instrumental ADLs (IADL) scale
timeFrame: 7-14 days after completing the 8 week intervention period and
measure: Instrumental ADLs (IADL) scale
timeFrame: 6 months after completing the intervention
measure: Sleep Diary
timeFrame: 7-14 days before scheduled surgery
measure: Sleep Diary
timeFrame: 7-14 days after hospital discharge
measure: Sleep Diary
timeFrame: During the 8 week intervention
measure: Sleep Diary
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Sleep Diary
timeFrame: 6 months after completing the intervention
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: 7-14 days before scheduled surgery
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: 6 months after completing intervention
measure: Hip disability and osteoarthritis outcome score (HOOS)
timeFrame: 7-14 days before scheduled surgery
measure: Hip disability and osteoarthritis outcome score (HOOS)
timeFrame: 6 months after completing intervention
measure: StepWatch
timeFrame: 7-14 days before scheduled surgery
measure: StepWatch
timeFrame: 7-14 days after hospital discharge
measure: StepWatch
timeFrame: 7-14 days after completing the 8 week intervention period
measure: StepWatch
timeFrame: 6 months after completing the intervention
Other outcomes:
measure: PROMIS Pain Intensity
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Pain Intensity
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Pain Intensity
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Pain Intensity
timeFrame: 6 months after completing the intervention
measure: PROMIS Pain Interference
timeFrame: 7-14 days before schedule surgery
measure: PROMIS Pain Interference
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Pain Interference
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Pain Interference
timeFrame: 6 months after completing the intervention
measure: PROMIS Fatigue
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Fatigue
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Fatigue
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Fatigue
timeFrame: 6 months after completing the intervention
measure: PROMIS Emotional Distress-Depressesion
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Emotional Distress-Depressesion
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Emotional Distress-Depressesion
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Emotional Distress-Depressesion
timeFrame: 6 months after completing the intervention
measure: PROMIS Psychosocial Illness Impact - Negative
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Psychosocial Illness Impact - Negative
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Psychosocial Illness Impact - Negative
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Psychosocial Illness Impact - Negative
timeFrame: 6 months after completing the intervention
measure: PROMIS Satisfaction with Social Roles and Activities
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Satisfaction with Social Roles and Activities
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Satisfaction with Social Roles and Activities
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Satisfaction with Social Roles and Activities
timeFrame: 6 months after completing the intervention
measure: PROMIS Ability to Participate in Social Roles and Activity
timeFrame: 7-14 days before scheduled surgery
measure: PROMIS Ability to Participate in Social Roles and Activity
timeFrame: 7-14 days after hospital discharge
measure: PROMIS Ability to Participate in Social Roles and Activity
timeFrame: 7-14 days after completing the 8 week intervention period
measure: PROMIS Ability to Participate in Social Roles and Activity
timeFrame: 6 months after completing the intervention
measure: Rehabilitation Attendance
timeFrame: From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks.
measure: Plasma IL-6
timeFrame: 7-14 days before scheduled surgery
measure: Plasma IL-6
timeFrame: 7-14 days after hospital discharge
measure: Plasma IL-6
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Plasma IL-6
timeFrame: 6 months after completing the intervention
measure: Plasma CRP
timeFrame: 7-14 days before scheduled surgery
measure: Plasma CRP
timeFrame: 7-14 days after hospital discharge
measure: Plasma CRP
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Plasma CRP
timeFrame: 6 months after completing the intervention
measure: Plasma VWF
timeFrame: 7-14 days before scheduled surgery
measure: Plasma VWF
timeFrame: 7-14 days after hospital discharge
measure: Plasma VWF
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Plasma VWF
timeFrame: 6 months after completing the intervention
measure: Plasma TNFalpha
timeFrame: 7-14 days before scheduled surgery
measure: Plasma TNFalpha
timeFrame: 7-14 days after hospital discharge
measure: Plasma TNFalpha
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Plasma TNFalpha
timeFrame: 6 months after completing the intervention
measure: Medication Monitoring Form
timeFrame: 7-14 days before schedule surgery
measure: Medication Monitoring Form
timeFrame: 7-14 days after hospital discharge
measure: Medication Monitoring Form
timeFrame: 7-14 days after completing the 8 week intervention period
measure: Medication Monitoring Form
timeFrame: 6 months after completing the intervention
measure: Treatment Expectation Questionnaire
timeFrame: Immediately prior to beginning the intervention
measure: Treatment Satisfaction Questionnaire
timeFrame: Immediately following the completion of the intervention
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Kelsey Seybold Clinic
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Sara Nowakowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: