Chronic Pain, Pain
Conditions
Keywords
Caregiving Dyad, Pain-related Disability
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMY-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
BEHAVIORALMY-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..
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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).
Intervention model description
Online intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Both members of the caregiving dyad: * Chronic musculoskeletal pain, present for a minimum of three months * Moderate or high levels of daily pain-related disability (BPI ≥ 5) * Part of caregiving dyad * Adults age 18 and over and able to speak English * Score \>4 out of 6 on the short Mini Mental Status Exam * Ability to stand with or without an assistive device * Sedentary lifestyle (i.e., any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents while in a sitting or reclining posture) Inclusion for care recipient only: -Living at home in the community (with or without caregiver) Inclusion for caregiver only: * Identified as the primary caregiver * Caregiver at least the past six months
Exclusion criteria
* Significant cardiovascular disease: New York Heart Association functional class 3 or 4 congestive heart failure; systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 105 mmHg; myocardial infarction within 3 months, chest pain or dizziness with exercise * Stroke, or Transient Ischemic Attack within 6 months * Respiratory conditions requiring use of oxygen at home (i.e., COPD) * Receiving or planning to receive, cancer treatment in the next 6 months * Alzheimer's disease, dementia; expectation of death in the next 12 months * In current physical rehabilitation, drug/alcohol treatment, or exercise research study * Completed self-management education in the last year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory | Administered at baseline and again following the 8-week intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 9 |
| 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). | 9 |
| 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). | 7 |
| 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). | 7 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Online Pilot, MY-Skills (Intervention), Caregivers | Online Pilot, MY-Skills (Intervention), Care Receivers | Online Pilot, MY-PLAN (Control), Caregivers | Online Pilot, MY-PLAN (Control), Care Receivers | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.33 years STANDARD_DEVIATION 20.72 | 65.00 years STANDARD_DEVIATION 18.97 | 37.57 years STANDARD_DEVIATION 12.73 | 39.86 years STANDARD_DEVIATION 21.04 | 52.19 years STANDARD_DEVIATION 21.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 4 Participants | 5 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 6 Participants |
| PROMIS-29 Profile v2 | 78.56 units on a scale STANDARD_DEVIATION 12.05 | 80.22 units on a scale STANDARD_DEVIATION 16.08 | 69.17 units on a scale STANDARD_DEVIATION 12.47 | 88.57 units on a scale STANDARD_DEVIATION 3.95 | 79.48 units on a scale STANDARD_DEVIATION 13.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 6 Participants | 7 Participants | 28 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 1 Participants | 6 Participants | 21 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 6 Participants | 0 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 14 |
| other Total, other adverse events | 0 / 18 | 0 / 14 |
| serious Total, serious adverse events | 1 / 18 | 1 / 14 |
Outcome results
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.
Time frame: Administered at baseline and again following the 8-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Pilot, MY-Skills (Intervention), Caregivers | Brief Pain Inventory | 0.23 Change in score of units on a scale | Standard Deviation 1.34 |
| Online Pilot, MY-Skills (Intervention), Care Receivers | Brief Pain Inventory | -0.29 Change in score of units on a scale | Standard Deviation 1.63 |
| Online Pilot, MY-PLAN (Control), Caregivers | Brief Pain Inventory | -1.38 Change in score of units on a scale | Standard Deviation 1.83 |
| Online Pilot, MY-PLAN (Control), Care Receivers | Brief Pain Inventory | -1.32 Change in score of units on a scale | Standard Deviation 1.87 |