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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AT012309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (BP-PEHD). Community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility.
Supported by the National Center for Complementary and Integrative Health through the National Institutes of Health's HEAL initiative (https://heal.nih.gov/)"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partners4Pain program | Experimental | adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status |
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| Key to Wellbeing program | Active Comparator | adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partners4Pain program | Other | Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility: # of Enrolled Participants | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants | 2 months |
| Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups; | 2 months |
| Participant Retention Feasibility: Primary Outcome Measurement | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention | 2 months |
| Intervention Delivery Feasibility: Participant Engagement | Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions | 9 weeks |
| Intervention Fidelity: Facilitator Delivery of Required Activities | Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities during at least 90% of sessions | 9 weeks |
| Data Collection Feasibility: Completion of Self-reported Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roni Evans, PhD, DC,MS | University of Minnesota | Principal Investigator |
| Brent Leininger, PhD, DC, MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Partners4Pain Program | Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2023 |
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| Key to Wellbeing program | Other | Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks |
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Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)
| 2 months |
| Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events | Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the interventions | 9 weeks |
| Safety and Tolerability of the Interventions: Satisfaction With Program | Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program | 9 weeks |
| FG001 |
| Key to Wellbeing Program |
Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Partners4Pain Program | Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks |
| BG001 | Key to Wellbeing Program | Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Ethnicity using 2020 U.S. census questionnaire | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race using 2020 U.S. census questionnaire | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pain, Enjoyment of Life and General Activity (PEG) | Three questions about the past week's pain. One question asks about pain severity and two questions ask about pain interference. Each item is rated on a 0-10 scale. Responses are added together and divided by three to get a final score ranging from 0 to 10. A higher score indicates more severe pain and pain-related interference with life and activities. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility: # of Enrolled Participants | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants | Posted | Count of Participants | Participants | 2 months |
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| Primary | Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups; | Posted | Count of Participants | Participants | 2 months |
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| Primary | Participant Retention Feasibility: Primary Outcome Measurement | Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention | Posted | Count of Participants | Participants | 2 months |
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| Primary | Intervention Delivery Feasibility: Participant Engagement | Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions | Posted | Count of Participants | Participants | 9 weeks |
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| Primary | Intervention Fidelity: Facilitator Delivery of Required Activities | Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities during at least 90% of sessions | Posted | Count of Units | Sessions | 9 weeks | Sessions | Sessions |
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| Primary | Data Collection Feasibility: Completion of Self-reported Outcomes | Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study) | Posted | Count of Participants | Participants | 2 months |
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| Primary | Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events | Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the interventions | Posted | Count of Participants | Participants | 9 weeks |
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| Primary | Safety and Tolerability of the Interventions: Satisfaction With Program | Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program | Posted | Count of Participants | Participants | 9 weeks |
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9 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Partners4Pain Program | Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks | 0 | 26 | 0 | 26 | 8 | 26 |
| EG001 | Key to Wellbeing Program | Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks | 0 | 25 | 2 | 25 | 14 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Motor Vehicle Accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening back or neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Increased muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Feeling more upset than usual when reminded of the past | Psychiatric disorders | Systematic Assessment |
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| Increased feelings of sadness | Psychiatric disorders | Systematic Assessment |
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| Increased feelings of anxiousness | Psychiatric disorders | Systematic Assessment |
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| Feeling more tired or fatigued than usual | General disorders | Systematic Assessment |
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| Feeling more isolated or lonely | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brent Leininger | University of Minnesota | 6126266477 | lein0122@umn.edu |
| Dec 4, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2023 | Jan 3, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| Male |
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| Mexican, Mexican American, Chicano |
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| Another Hispanic, Latino, or Spanish origin (e.g. Savadorian, Dominican, Columbian, Guatemalan, etc) |
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| White (German, Irish, English, Italian, Lebanese, Egyptian, etc.) |
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| Chinese |
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| Asian Indian |
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| Other Asian (Pakistani, Cambodian, Hmong, etc.) |
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| American Indian or Alaska Native |
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| Other Race (Mestizo) |
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| Other Race (Mexican) |
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| More Than One Race |
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