Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Half of all Veterans who seek care from the Veterans Health Administration (VHA) experience chronic musculoskeletal pain. First-line treatment for chronic pain should include nonpharmacological interventions. Although Veterans have access to these interventions, there is no standardized process to personalize them to meet the needs of individual Veterans despite the fact that personalization and self-care are key components of the VHA's Stepped Care Model for pain management. This proposal seeks to adapt and evaluate a coaching intervention that will be a personalized approach to help Veterans develop and maintain pain self-care plans. The proposed research responds to VHA's strategic objectives to tailor service delivery (obj. 2.2) and develop or adapt interventions that improve Veteran outcomes (obj. 2.4).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
U.S. military Veteran
Chronic musculoskeletal pain defined by the National Health Interview Survey (pain that has been present on most days for the past 3 months)
Disqualifiers
Moderate to Severe cognitive impairment
Severe or untreated substance use disorder
Severe or untreated mental health condition
Enrolled in hospice or palliative care with life expectancy <12 months
Trial design
Design model
Parallel
Treatments tested in this trial
Coaching
BehavioralThe intervention will likely incorporate health coaching to support participants in developing and maintaining their pain self-care plans. Details of the intervention will be updated prior to enrollment because the core components may changed based on findings from stages 1 and 2 (aims 1 and 2).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment (number enrolled out of all eligible and asked to participate)
Recruitment rate is defined as the proportion of Veterans who enroll in the feasibility study out of all those eligible who were asked to participate.
Time frame
Baseline2
Retention (number who complete intervention and outcomes at post-intervention out of all enrolled)
Retention is defined as the proportion of Veterans who complete the intervention (anticipated timeframe of 3 months) and the proportion who complete the post-intervention outcomes (anticipated 3 months) and follow-up outcomes (anticipated 6 months)
Time frame
3 Months (primary) and 6 MonthsSecondary outcomes
1
Feasibility of Intervention Measure (scale)
The Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater feasibility of the program. Feasibility will be evaluated post-program (anticipated 3 months).
Time frame
3 Months2
Acceptability of Intervention Measure (scale)
The Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater acceptability of the program. Feasibility will be evaluated post-program (anticipated 3 months).
Time frame
3 Months3
Intervention Appropriateness Measure (scale)
The Intervention Appropriateness Measure consists of 4 items rated on a 5-point Likert scale from (1) complete disagree to (5) completely agree. Mean scores are reported and can range from 1 to 5. Higher scores indicate greater appropriateness of the program. Feasibility will be evaluated post-program (anticipated 3 months).
Time frame
3 Months4
Pain intensity and interference
Pain intensity and interference will be measured by the PEG-3 (Pain intensity, interference with Enjoyment of life, and interference with General activity) scale. The PEG-3 is a 3-item measure that is valid for individuals with chronic pain and is sensitive to change. Mean of the three individual item scores are reported and can range from 0 to 10. Lower scores indicated less pain intensity and interference.
Time frame
Baseline, 3 Months, 6 MonthsSponsors and contacts
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Source ClinicalTrials.gov
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