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| ID | Type | Description | Link |
|---|---|---|---|
| RX003302-01A1 | Other Grant/Funding Number | VA RR&D |
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The proposed work will be a key step forward in fulfilling the mission of VA RR&D to restore function and enable social reintegration for Veterans. Development of an intervention to increase physical activity may improve physical functioning for Veterans with posttraumatic stress disorder (PTSD), thus addressing an important gap in existing care. If demonstrated to be efficacious in a future randomized trial, this intervention could be implemented throughout VHA to improve quality of life and enable a full recovery for many Veterans with PTSD. Results from the proposed work may also advance our understanding of how to optimally incorporate mobile health technology (mHealth) with more traditional types of patient contacts, such as in-person visits and telephone calls. Effective use of mHealth may offer greater flexibility for VHA clinics looking to implement new programs. Incorporation of mHealth may also increase access to clinical services for Veterans who reside far from VHA facilities.
Veterans with posttraumatic stress disorder (PTSD) have poor physical functioning and there are no existing interventions that effectively address this problem. Our long-term goal is to develop and implement effective interventions to improve physical functioning and reduce risk for adverse health outcomes for Veterans with PTSD. The overall objectives of the proposed project are to develop and pilot test a novel intervention aimed at initiating and maintaining higher levels of physical activity for Veterans with PTSD. This new intervention will address attitudinal and behavioral barriers to increasing physical activity for Veterans with PTSD. Particularly relevant barriers for those with PTSD may include low perceived behavioral control for making positive long-term lifestyle changes and personal attitudes about the harms (vs. benefits) of physical activity.
The proposed work will meet two specific aims: 1) Adapt graded exercise therapy (GET) and incorporate motivational interviewing and mobile health technology (mHealth) to increase physical activity for Veterans with PTSD; and 2) conduct a pilot study to examine the feasibility and acceptability of the intervention for a future randomized controlled trial. To achieve Aim 1, we will develop treatment manuals, training procedures for interventionists, and processes for assessment of intervention fidelity. The intervention will use GET to increase perceived behavioral control by enhancing knowledge about appropriate activities and helping participants set appropriate and attainable daily goals for physical activity. We will also incorporate motivational interviewing techniques and mHealth to enhance positive personal attitudes about physical activity. We will work with our Veteran Engagement Panel for PTSD to refine topics and communication materials. In Aim 2, we will enroll 3 groups of 6-8 participants (18-24 total) and use a concurrent mixed-methods approach to rapidly assess feasibility and acceptability. Quantitative measures will include recruitment (proportion enrolled out of total eligible); attendance (proportion who attend 75% of in-person visits); and retention (proportion who complete post-intervention data collection). Qualitative assessment will consist of semi-structured interviews on acceptability of intervention components (eg, format and topics of in-person visits, usability of mHealth), and barriers and facilitators to attendance. At baseline, during, and post-intervention, we will also measure overall and physical functioning, and collect data on other clinical variables (PTSD symptoms, depressive symptoms, pain, fatigue, and sleep quality) to inform a future effectiveness trial.
The proposed work is innovative because it is a novel combination of GET, motivational interviewing, and mHealth to increase physical activity. It will also be the first intervention to focus on changing physical activity as a means to improving physical functioning for individuals with PTSD. Successful experiences with this program may also help participants build confidence about their general ability to make positive changes related to health, thus increasing the likelihood they will engage in (and adhere to) mental health treatments. If such synergy is ultimately demonstrated, it will open a new direction for VA RR&D and VHA clinical care by indicating that interventions focusing on physical functioning should be more closely integrated with mental health services. Additionally, this project will be one of the first to collaborate with our Veteran Engagement Panel on PTSD research. The format of our panel is adapted from and builds upon previous models of patient stakeholder engagement. Our model addresses many of the barriers to effective stakeholder engagement, including challenges to timely recruitment of patients with relevant experiences, and lack of facilitation expertise among investigators. Completion of this project will help establish the utility of our model of Veteran stakeholder engagement for rapidly developing effective interventions with improved feasibility and acceptability. Thus, this work will enable incorporation of Veteran engagement in future VA research projects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity | Experimental | In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity | Behavioral | In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | total participants enrolled in intervention (out of total patients identified as eligible) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total # Participants Completing Acceptability Interviews | Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance | 4 months |
| Attendance |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks | 2 months |
| Physical Functioning | Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Denise Duan-Porter, MD PhD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States |
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24 participants completed informed consent and were enrolled but only 21 completed the baseline visits (required before moving onto the intervention)
Goal recruitment was 6-8 participants for each of 3 pilot groups (max 24 total). The actual number of participants enrolled reflects those who completed informed consent and attended the baseline assessment and education session with the physical therapist (6, 8, and 7 for 3 groups). Because this was a group intervention, if participants failed to attend the informed consent or baseline visit (including attempts at rescheduling), we were unable to recruit additional participants for that group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Activity | In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Activity | In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | total participants enrolled in intervention (out of total patients identified as eligible) | Data represents the total number of participants who completed informed consent | Posted | Count of Participants | Participants | 2 months |
|
|
4 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 | Physical Activity | In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation Physical Activity: In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation at wrist due to wearing fitness device | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wei Duan-Porter | Minneapolis VA Health Care System | 6124675845 | wei.duanporter@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 | Oct 20, 2021 | Apr 27, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2021 | Jun 6, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009043 | Motor Activity |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The intervention uses Graded Exercise Therapy to increase perceived behavioral control by enhancing knowledge about appropriate activities and helping participants set appropriate and attainable daily goals for physical activity. We will also incorporate motivational interviewing techniques and mHealth to enhance positive personal attitudes about physical activity.
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Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls)
| 1 month |
| Retention | Number of participants who complete post-intervention assessments at 4 months follow-up | 4 months |
| 4 months |
| PTSD Symptoms | PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse) | 4 months |
| Depressive Symptoms | Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse) | 4 months |
| Pain Intensity and Interference | PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference | 4 months |
| Fatigue | Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue | 4 months |
| Sleep-related Impairment | PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep | 4 months |
| 6 Minute Walk | distance walked in 6 min (in meters) | 4 months |
| Sit to Stand | # of sit-to-stands completed in 30 seconds | 4 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
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| Secondary | Total # Participants Completing Acceptability Interviews | Number of participants who completed interviews on usability of wearable device; barriers and facilitators to attendance | Participants who enrolled in study and were invited to interviews | Posted | Count of Participants | Participants | 4 months |
|
|
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| Secondary | Attendance | Number of participants who attended 75% of session visits (3 out of 4 group sessions; 5 of 7 individual follow-up calls) | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Retention | Number of participants who complete post-intervention assessments at 4 months follow-up | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Other Pre-specified | Physical Activity | Activity tracking (wearable device), number of days meeting activity goal (per week) at 8 weeks | Posted | Mean | Standard Deviation | days meeting activity goal/week | 2 months |
|
|
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| Other Pre-specified | Physical Functioning | Physical Component Score of Veterans Short-Form 36 item survey; range 0-100 (standardized), higher is better functioning | Participants who completed 4 months follow-up surveys | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| Other Pre-specified | PTSD Symptoms | PTSD Checklist for DSM V; range 0-80, higher is more symptoms (worse) | Complete baseline and follow-up data | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| Other Pre-specified | Depressive Symptoms | Patient health questionnaire 8-item; range 0-24, higher is more symptoms (worse) | complete follow-up data | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| Other Pre-specified | Pain Intensity and Interference | PEG (brief 3-item scale on intensity and interference), range 0-10, higher is more pain/interference | complete follow-up data | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| Other Pre-specified | Fatigue | Patient Reported Outcomes Measurement Information System (PROMIS) fatigue 4-item short form, range 0-100 (standardized), higher is more fatigue | participants with complete follow-up data | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Other Pre-specified | Sleep-related Impairment | PROMIS sleep measure, standardized T score (0-100), higher is poorer sleep | complete follow-up data | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
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| Other Pre-specified | 6 Minute Walk | distance walked in 6 min (in meters) | complete follow-up data | Posted | Mean | Standard Deviation | meters | 4 months |
|
|
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| Other Pre-specified | Sit to Stand | # of sit-to-stands completed in 30 seconds | complete follow-up data | Posted | Mean | Standard Deviation | sit-to-stand events | 4 months |
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| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |