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This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3), the investigators will conduct a single-arm pilot study of 40 rural VA patients with chronic pain to assess study feasibility (recruitment and retention), intervention feasibility (fidelity of intervention delivery and participant engagement rates), acceptability, and effectiveness at addressing pre-defined capabilities, opportunities and motivations.
Pain is a complex biophysical, psychological, and social condition and there is a growing evidence base to support several complementary and integrative health (CIH) approaches, which can address pain in a more holistic way. While the VA has become a leader in advancing CIH through its Whole Health Initiative, there remain many barriers, especially for rural patients. This pilot study will assess the feasibility of an innovative telehealth evidence-based intervention for rural VA patients with chronic pain: the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP was developed with multiple-levels of VA stakeholders (including rural patients). It was designed to deliver multiple CIH self-management strategies (pain education, mindfulness, pain specific exercises, and cognitive behavioral strategies) in one intervention, to overcome existing barriers to care and improve rural Veterans' pain and important biopsychosocial outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAMP program | Behavioral | The RAMP program is a 12-week virtual program consisting of an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Recruited | Number of participants recruited | 3 months |
| Female Participants Recruited | Percentage of Female Participants Recruited | 3 months |
| Racial/Ethnic Minoritized Participants Recruited | Percentage of Racial/Ethnic Minoritized Participants Recruited | 3 months |
| Participant Satisfaction | Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale | 3 months |
| Participant Engagement | Percentage of participants who participated in at least 7 out of 12 sessions either by attending the group session (i.e., synchronous participation) or reporting that they completed any of the session activities on their own (i.e., asynchronous participation) | 3 months |
| Fidelity of Intervention Delivery | Two experts in developing and delivering mind-body interventions for pain independently observed 10% of sessions via videoconference using a structured checklist. | 3 months |
| Survey Response Rate | Percentage of participants completing post-treatment data collection | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VAMC | Minneapolis | Minnesota | 55417 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The RAMP intervention consisted of a 12-week virtual program including an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The RAMP intervention consisted of a 12-week virtual program including an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions. |
| 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 |
| 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 | Participants Recruited | Number of participants recruited | Posted | Count of Participants | Participants | 3 months |
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From consent until 30 days after the last day of study participation (5 months on average).
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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 | Intervention | The RAMP intervention consisted of a 12-week virtual program including an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Burgess, MPI | Minneapolis VA Medical Healthcare System | 612-467-1591 | diana.burgess@va.gov |
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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 | Aug 22, 2025 | Dec 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Primary | Female Participants Recruited | Percentage of Female Participants Recruited | Posted | Count of Participants | Participants | 3 months |
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| Primary | Racial/Ethnic Minoritized Participants Recruited | Percentage of Racial/Ethnic Minoritized Participants Recruited | Posted | Count of Participants | Participants | 3 months |
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| Primary | Participant Satisfaction | Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale | Posted | Count of Participants | Participants | 3 months |
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| Primary | Participant Engagement | Percentage of participants who participated in at least 7 out of 12 sessions either by attending the group session (i.e., synchronous participation) or reporting that they completed any of the session activities on their own (i.e., asynchronous participation) | Posted | Count of Participants | Participants | 3 months |
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| Primary | Fidelity of Intervention Delivery | Two experts in developing and delivering mind-body interventions for pain independently observed 10% of sessions via videoconference using a structured checklist. | Posted | Count of Units | sessions | 3 months | sessions | sessions |
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| Primary | Survey Response Rate | Percentage of participants completing post-treatment data collection | Posted | Count of Participants | Participants | 3 month |
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| 0 |
| 40 |
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| 40 |
| 0 |
| 40 |
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