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| ID | Type | Description | Link |
|---|---|---|---|
| 1410626162 | Other Identifier | Indiana University |
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To maximize implementation potential of pain self-management in the VA, alternative delivery methods are needed to provide Veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain.
The investigators' goal is to test the effectiveness of a peer coaching model among Veterans. The investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation.
Aim 1 (primary aim): To compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function).
Hypothesis 1: Veterans in the peer support arm will experience reduced overall pain compared to controls.
Aim 2 (secondary aim): To compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization.
Hypothesis 2: Veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls.
Aim 3 (pre-implementation aim): To explore facilitators and barriers to implementation of peer support for chronic pain, intervention costs, and fidelity to the model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Coach Assignment | Experimental | Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. |
|
| Control | No Intervention | Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Coach Assignment | Behavioral | Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) (Overall Pain Assessment) | The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable) | 6 months |
| Brief Pain Inventory (BPI) (Overall Pain Assessment) | The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing) | 6 months |
| Perceived Social Support |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Sassi Matthias, PhD MS BA | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30951837 | Result | Matthias MS, Daggy J, Adams J, Menen T, McCalley S, Kukla M, McGuire AB, Ofner S, Pierce E, Kempf C, Heisler M, Bair MJ. Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics. Contemp Clin Trials. 2019 Jun;81:71-79. doi: 10.1016/j.cct.2019.04.002. Epub 2019 Apr 2. | |
| 30481295 |
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Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.
The data will become available once the study team completes all analyses.
The Research Service will evaluate individual requests.
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Two participants who enrolled withdrew prior to completing baseline assessments, leaving 119 randomized to the intervention and 94 to the control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Coach Assignment | Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management. |
| FG001 | Control | Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Coach Assignment | Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Brief Pain Inventory (BPI) (Overall Pain Assessment) | The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable) | 21 withdrew and 14 were lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
9 months
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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 | Peer Coach Assignment | Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period. Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert O'Brien | VA ORD | 2024435741 | Robert.O'Brien2@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 | Jul 1, 2015 | Aug 6, 2020 | 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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Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support) |
| 6 months |
| Perceived Social Support | Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support) | 9 months |
| Self Efficacy | Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy) | 6 months |
| Self Efficacy | Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy) | 9 months |
| Anxiety | GAD-7 (Range 0-21, higher numbers = higher anxiety) | 6 months |
| Anxiety | GAD-7 (Range 0-21, higher numbers = higher anxiety) | 9 months |
| Depression | PHQ-8 (Range: 0-24, higher numbers = higher depression) | 6 months |
| Depression | PHQ-8 (Range: 0-24, higher numbers = higher depression) | 9 months |
| Pain Catastrophizing | Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing) | 9 months |
| Patient Activation | Patient Activation Measure (Range: 0-100, higher numbers = higher activation) | 6 months |
| Patient Activation | Patient Activation Measure (Range: 0-100, higher numbers = higher activation) | 9 months |
| General Health Perceptions | SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions) | 6 months |
| General Health Perceptions | SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions) | 9 months |
| Shue SA, McGuire AB, Matthias MS. Facilitators and Barriers to Implementation of a Peer Support Intervention for Patients with Chronic Pain: A Qualitative Study. Pain Med. 2019 Jul 1;20(7):1311-1320. doi: 10.1093/pm/pny229. |
| 32044190 | Result | Matthias MS, Daggy J, Ofner S, McGuire AB, Kukla M, Bair MJ. Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain. Patient Educ Couns. 2020 Jul;103(7):1366-1372. doi: 10.1016/j.pec.2020.02.007. Epub 2020 Feb 5. |
| 32700220 | Result | Matthias MS, Bair MJ, Ofner S, Heisler M, Kukla M, McGuire AB, Adams J, Kempf C, Pierce E, Menen T, McCalley S, Johnson NL, Daggy J. Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial. J Gen Intern Med. 2020 Dec;35(12):3525-3533. doi: 10.1007/s11606-020-06007-6. Epub 2020 Jul 22. |
| 34718764 | Derived | Matthias MS, Hirsh AT, Ofner S, Daggy J. Exploring the Relationships Among Social Support, Patient Activation, and Pain-Related Outcomes. Pain Med. 2022 Apr 8;23(4):676-685. doi: 10.1093/pm/pnab306. |
Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Brief Pain Inventory Total | Range: 0-10 (0 = no pain; 10 = worst pain imaginable) | Mean | Standard Deviation | units on a scale |
|
| Perceived Social Support | Range: 12-24 (higher numbers = greater social support) | Mean | Standard Deviation | units on a scale |
|
| Self-Efficacy | Range: 0-10 (higher numbers = higher self-efficacy) | Mean | Standard Deviation | units on a scale |
|
| Anxiety | Generalized Anxiety Disorder-7 (GAD-7, 0-21, higher numbers = higher anxiety) | Mean | Standard Deviation | units on a scale |
|
| Depression | Patient Health Questionnaire (PHQ-8, 0-24, higher numbers = higher depression) | Mean | Standard Deviation | units on a scale |
|
| Pain Catastrophizing | Range: 0-52 (higher numbers = higher catastrophizing) | Mean | Standard Deviation | units on a scale |
|
| Patient Activation | Patient Activation Measure (0-100, higher numbers = higher activation) | Mean | Standard Deviation | units on a scale |
|
| General Health Perceptions | SF-36 (Range: 0-100, higher numbers equal higher health perceptions) | Mean | Standard Deviation | units on a scale |
|
Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management.
|
|
|
| Primary | Brief Pain Inventory (BPI) (Overall Pain Assessment) | The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable) | 7 withdrew and 4 were lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | Pain Catastrophizing | Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing) | 21 withdrew and 14 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Perceived Social Support | Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support) | 21 withdrew and 14 lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Perceived Social Support | Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support) | 7 withdrew and 4 were lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | Self Efficacy | Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy) | 21 withdrew and 14 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Self Efficacy | Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy) | 7 withdrew and 4 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | Anxiety | GAD-7 (Range 0-21, higher numbers = higher anxiety) | 21 withdrew and 14 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Anxiety | GAD-7 (Range 0-21, higher numbers = higher anxiety) | 7 withdrew and 4 lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | Depression | PHQ-8 (Range: 0-24, higher numbers = higher depression) | 21 withdrew and 14 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Depression | PHQ-8 (Range: 0-24, higher numbers = higher depression) | 7 withdrew and 4 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | Pain Catastrophizing | Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing) | 7 withdrew and 4 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | Patient Activation | Patient Activation Measure (Range: 0-100, higher numbers = higher activation) | 21 withdrew and 14 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Patient Activation | Patient Activation Measure (Range: 0-100, higher numbers = higher activation) | 7 withdrew and 4 were lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| Secondary | General Health Perceptions | SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions) | 21 withdrew and 14 lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | General Health Perceptions | SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions) | 7 withdrew and 4 were lost to follow up | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
|
|
| 0 |
| 119 |
| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | Control | Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management. | 0 | 94 | 0 | 94 | 0 | 94 |
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