Insomnia, Osteoarthritis, Hip, Osteoarthritis, Knee, Pain
Conditions
Keywords
Knee Arthroplasty, Hip Arthroplasty, Rehabilitation
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.
Interventions
BEHAVIORALHealthy 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.
BEHAVIORALSleep 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.
Sponsors
Baylor College of Medicine
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be assigned to either the a healthy habits group or a sleep habits group.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Change from Baseline to 7-14 days after 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 ≥ 8 is optimal to detect clinical levels of insomnia. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSara Nowakowski, PhD
Baylor College of Medicine
Participant flow
Recruitment details
3 Recruitment Hospitals: 1. Kelsey Seybold Clinic 2. Baylor College of Medicine 3. University of Texas Medical Branch
Pre-assignment details
Prior to randomization two assessment visits occurred: 1. Pre-Surgery 2. Post-Surgery Following total hip or knee joint arthroplasty, participants were randomized to one of two study intervention arms. A total of 73 participants provided informed consent and were enrolled. Three participants did not proceed to randomization: one whose scheduled surgery was canceled following an abnormal pre-operative evaluation and who elected not to continue; one who withdrew shortly after consent after learn
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.79 Years STANDARD_DEVIATION 8.39 |
| Body Mass Index (BMI) | 33.25 kg/m^2 STANDARD_DEVIATION 1.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
None listed