Insomnia Related to Osteoarthritis Pain Clinical Trial
— OATSOfficial title:
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
| Verified date | March 2020 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance. This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia. The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.
| Status | Active, not recruiting |
| Enrollment | 327 |
| Est. completion date | November 2020 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - Age 60+ with one or more health care visits for OA in the prior 3 years - Score of =6 on 4-item ISI at first screening and =11 on full ISI at second screening - Score of =9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening Exclusion Criteria: - Not continuously enrolled at Group Health Cooperative for at least one year - Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder - Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months - Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (>6 on the Short Orientation-Memory-Concentration Test) - Hearing or speech impairment sufficient to preclude participation in a telephone intervention |
| Country | Name | City | State |
|---|---|---|---|
| United States | Kaiser Permanente Washington Research Institute | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | Kaiser Permanente |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Insomnia Severity Index (ISI) | A 7-item questionnaire that is a global measure of perceived insomnia severity. Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. | 12 months post baseline | |
| Secondary | Insomnia Severity Index (ISI) | A 7-item questionnaire that is a global measure of perceived insomnia severity.Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. | 2 months post baseline | |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Self-rating of overall sleep quality and disturbances using 7 sleep. components. PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers. | 2 months post baseline | |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Self-rating of overall sleep quality and disturbances using 7 sleep components. PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers. | 12 months post baseline | |
| Secondary | Brief Pain Inventory-short form (BPI-sf) | A questionnaire to assess pain intensity and interference with activities. The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients. | 2 months post baseline | |
| Secondary | Brief Pain Inventory-short form (BPI-sf) | A questionnaire to assess pain intensity and interference with activities. The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients. | 12 months post baseline | |
| Secondary | Flinders Fatigue Scale (FFS) | A 7-item self-report questionnaire to measure fatigue level in a variety of situations. | 2 months post baseline | |
| Secondary | Flinders Fatigue Scale (FFS) | A 7-item self-report questionnaire to measure fatigue level in a variety of situations. | 12 months post baseline | |
| Secondary | Patient Health Questionnaire (PHQ-8) | 4-point scale rates frequency of occurrence of 8 depressive symptoms. | 2 months post baseline | |
| Secondary | Patient Health Questionnaire (PHQ-8) | 4-point scale rates frequency of occurrence of 8 depressive symptoms. | 12 months post baseline | |
| Secondary | Sleep Hygiene Index (SHI) | A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time. | 2 months post baseline | |
| Secondary | Sleep Hygiene Index (SHI) | A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time. | 12 months post baseline | |
| Secondary | EuroQoL 5D (EQ-5D) | Rates health status on five dimensions and overall health status from 0 to 100. The most widely used measure in clinical trials assessing general quality of life of OA patients. | 2 months post baseline | |
| Secondary | EuroQoL 5D (EQ-5D) | Rates health status on five dimensions and overall health status from 0 to 100. The most widely used measure in clinical trials assessing general quality of life of OA patients. | 12 months post baseline | |
| Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities. It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies. | 2 months post baseline | |
| Secondary | Western Ontario and McMaster Universities Arthritis Index (WOMAC) | A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities. It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies. | 12 months post baseline | |
| Secondary | Use of sleep and pain medications | NSAID, analgesic, sedative, and anti-depressant medication use. | Baseline through 24 months | |
| Secondary | Outpatient visits | The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis. | Baseline through 24 months | |
| Secondary | Health care costs | The Group Health cost database will be used to estimate costs (from study entry to 24 months post enrollment) of ambulatory healthcare for all conditions, arthritis and sleep problems, and inpatient care. | Baseline through 24 months |