Clinical trial NCT06183281: Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
Official title: Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity (INSPIRE): Tailored Digital Tools, Telehealth Coaching, and Primary Care Coordination
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Non-malignant chronic pain
Digital health
Health coaching
Health equity
Cognitive therapy
Mindfulness
Movement
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-12-27
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into intervention or enhanced usual care conditions
Primary purpose: TREATMENT

Brief summary: INSPIRE creates a trilingual mobile app and telehealth coaching program to promote non-pharmacologic strategies for pain management with Black, Chinese, and Latinx communities in the San Francisco Bay Area. Years 1-2 will develop the app and test it with a brief single arm pilot starting in Nov 2023. A full two arm randomized controlled trial (RCT) will being in early 2025 with changes in PEG scores as the primary outcome. Secondary outcomes include Helping to End Addiction Longterm (HEAL) common data elements.


Eligibility criteria: Inclusion Criteria:

1. age 18 or older
2. speak English, Spanish, or Cantonese
3. have a UCSF Health or SFHN PCP
4. be willing to use a smartphone (iOS or Android - either their own or one provided by the study)
5. have chronic, non-malignant pain for at least 3 months
6. be willing to participate in a 12 month patient-centered chronic pain management study where they will be randomized into one of two comparison arms

Exclusion Criteria:

* Severe mental illness or other condition preventing informed consent

Primary outcomes:
measure: Change from Baseline in Pain Intensity and Interference on the 11-point Pain, Enjoyment of Life, and General Activity Scale (PEG)
timeFrame: Baseline, 3mo, 6mo, 12mo
Secondary outcomes:
measure: Change from Baseline in Physical Functioning on the 5-point PROMIS Physical Function Short Form 6b
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Sleep Disturbance and Sleep Duration on the 5-point PROMIS Sleep Disturbance Short Form 6a
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Fear and Anxiety about Pain on the 5-point Pain Catastrophizing Scale Short Form 6
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Self-reported Depressive Symptoms on the 4-point Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Self-reported Anxiety Symptoms on the 4-point General Anxiety Scale (GAD-7)
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Overall Satisfaction with Treatment on the 7-point Patient Global Impression of Change (PGIC)
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Self-reported Alcohol Use Disorder Symptoms on the 5-point Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Drug Abuse Screening Test (DAST) Score
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Internalized Stigma of Mental Illness on the 4-point Internalized Stigma of Mental Illness Inventory (ISMI)
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Self-reported Social Isolation on the 5-point PROMIS Social Isolation Short Form 8a
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Clinician Self-reported Attitudes, Beliefs, and Perspectives about Mental Illness on the 5-point Opening Minds Survey for Health Care Providers
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Patient Self-reported Trust of their Healthcare Provider(s) on the 5-point PROMIS Healthcare Relationship Trust (HCR) Scale
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Self-reported Pain Self-Efficacy on the 7-point Pain Self-Efficacy Questionnaire - Two Item Short Form (PSEQ-2)
timeFrame: Baseline, 3mo, 6mo, 12mo
measure: Change from Baseline in Self-reported Psychological Inflexibility on the 7-point Psychological Inflexibility in Pain Scale
timeFrame: Baseline, 3mo, 6mo, 12mo
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Adult Primary Care Mt. Zion Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jason Satterfield, PhD
role: PRINCIPAL_INVESTIGATOR
References: