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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009688 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group.
Aim 2: Assess feasibility and acceptability of an online intervention, the Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will include 30 caregiving dyads randomly assigned to the two groups (15 dyads for Education and Gentle Exercise, and 15 dyads for control group; N = 30 dyads/60 participants). The primary hypothesis is that Education and Gentle Exercise will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities.
The long-term goal of this study is to advance best practices in complementary and integrative health (CIH) to improve health for caregivers and individuals with chronic disabilities. This proposal is focused on merging exercise and education to improve pain for individuals in a caregiving dyad. The objective of this study is to develop and test the online Education and Gentle Exercise intervention, thus, addressing the critical need for innovative pain interventions focusing on the caregiving dyad. To achieve this objective and support a future randomized controlled trial (RCT), the researchers will conduct a mixed-methods study, including a small RCT.
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group.
Aim 2: Assess feasibility and acceptability of online Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will be assigned to one of the the two groups. The primary hypothesis is that the online Education and Gentle Exercise intervention will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted online to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities. To assess change on the primary outcome (pain-related disability) and secondary outcome measures, members of the caregiving dyad will complete pre and post-assessments guided by the Biopsychosocial model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MY-Skills Intervention - online | Experimental | Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain. |
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| MY-Plan control - online | Active Comparator | Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of light exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MY-SKILLS - online | Behavioral | Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory | Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference. Caregiver and care receiver completed the assessment on their own pain. | Administered at baseline and again following the 8-week intervention |
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Inclusion Criteria:
Both members of the caregiving dyad:
Inclusion for care recipient only:
-Living at home in the community (with or without caregiver)
Inclusion for caregiver only:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arlene Schmid, PhD | Colorado State University | Principal Investigator |
| Christine Fruhauf, PhD | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University | Fort Collins | Colorado | 80523 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39421567 | Derived | Schmid AA, Fruhauf CA, Fox AL, Sharp JL, Portz JD, Leach HJ, Van Puymbroeck M. A pilot study to establish feasibility and acceptability of a yoga and self-management education intervention to support caregivers and care receivers with persistent pain. Front Rehabil Sci. 2024 Oct 3;5:1397220. doi: 10.3389/fresc.2024.1397220. eCollection 2024. | |
| 37223971 | Derived | Portz JD, Schmid A, Fruhauf C, Fox A, Van Puymbroeck M, Sharp J, Leach H. Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study. JMIR Form Res. 2023 May 24;7:e39158. doi: 10.2196/39158. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MY-Skills Intervention - Online | MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain |
| FG001 | MY-Plan Control - Online | MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Online Pilot, MY-Skills (Intervention), Caregivers | Participants in the MY-Skills program who provide the most care to their partner (other member of the dyad). |
| BG001 | Online Pilot, MY-Skills (Intervention), Care Receivers |
| 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 | Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity and interference. Caregiver and care receiver completed the assessment on their own pain. | Posted | Mean | Standard Deviation | Change in score of units on a scale | Administered at baseline and again following the 8-week intervention |
|
9 months, the span of time we conducted every intervention cohort
Serious adverse event information collected and evaluated by our Institutional Review Board.
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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 | MY-Skills Intervention - Online | MY-SKILLS - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extreme leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | SAE did not happen during active intervention/control. Participant hospitalized for extreme leg pain, received care, and released. Returned the next week, resumed sessions with med clearance. The SAE was deemed not related to the study by the IRB. |
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Very specific inclusion and exclusion criteria (requiring high levels of pain severity and interference and low levels of physical activity) may have limited our ability to recruit a larger number of eligible individuals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Arlene Schmid | Colorado State University | 970-491-7562 | arlene.schmid@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2021 | Jun 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2021 | Jun 17, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2020 | Jun 17, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Online intervention
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Demographic data and measures will be collected by a blinded and trained research assistant.
The assessor and participants will be blinded to the randomization. We will maintain assessor and participant blinding through established mechanisms (e.g., not discussing information or intervention).
| MY-Plan control - online | Behavioral | Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.. |
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Participants in the MY-Skills program who receive the most care from their partner (other member of the dyad).
| BG002 | Online Pilot, MY-PLAN (Control), Caregivers | Participants in the MY-PLAN control group who provide the most care to their partner (other member of the dyad). |
| BG003 | Online Pilot, MY-PLAN (Control), Care Receivers | Participants in the MY-PLAN control group who receive the most care from their partner (other member of the dyad). |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | unreported data from one participant | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| PROMIS-29 Profile v2 | unreported data from one participant | Mean | Standard Deviation | units on a scale |
|
| OG001 | Online Pilot, MY-Skills (Intervention), Care Receivers | Participants in the MY-Skills program who receive the most care from their partner (other member of the dyad). |
| OG002 | Online Pilot, MY-PLAN (Control), Caregivers | Participants in the MY-PLAN control group who provide the most care to their partner (other member of the dyad). |
| OG003 | Online Pilot, MY-PLAN (Control), Care Receivers | Participants in the MY-PLAN control group who receive the most care from their partner (other member of the dyad). |
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| 0 |
| 18 |
| EG001 | MY-Plan Control - Online | MY-Plan control - online: Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain.. | 0 | 14 | 1 | 14 | 0 | 14 |
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| High blood pressure | Cardiac disorders | Non-systematic Assessment | SAE did not occur during active intervention/control. Participant hospitalized for high blood pressure and dizziness, received care and released with new medication. Resumed sessions with med clearance. SAE deemed not related to study by IRB. |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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