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Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.
In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants receive no intervention. | |
| Self-management program (SMP) | Active Comparator | Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks. |
|
| Self-management program (SMP) with Health Behavior Change Counseling (HBCC) | Experimental | Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks and receive three telephone-based health behavioral change counseling sessions based on the principles and practices of motivational interviewing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Behavior Change Counseling | Behavioral | A telephone-based intervention employing principles and practices of motivational interviewing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of research | Acceptability - at least 50% of individuals approached agree to eligibility screening for the study, having at least 30% of those who were deemed eligible for the study agree to participate | Baseline |
| Feasibility of study | Feasibility - (1) having at least 80% of enrolled participants attend at least 3 of the 6 scheduled self-management program sessions; and (2) having a loss to follow-up rate of < 20% of enrolled participants over the 26-week study | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure (PAM) score | The Patient Activation Measure (PAM) is a 13-item instrument where patients are provided 5 response options, ranging from "strongly agree" to "strongly disagree." Based on their answers, patients were assigned a numerical score ranging from 0 (no activation) to 100 (highest activation), and the score was used to stratify patients into 1 of 4 stages of activation: stage 1 (believes taking an active role is important), stage 2 (has the confidence and knowledge to take action), stage 3 (takes action), and stage 4 (stays the course under stress) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Skolasky | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39085831 | Derived | Skolasky RL, Nolan S, Pierre R, Vinch P, Taylor JL. Nurse-led web-based self-management program to improve patient activation and health outcomes in patients with chronic low back pain: an acceptability and feasibility pilot study. BMC Nurs. 2024 Jul 31;23(1):524. doi: 10.1186/s12912-024-02155-w. |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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The outcomes assessors were masked to treatment assignment
| Self-management program | Behavioral | An evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program. |
|
| 12 weeks |
| Oswestry Disability Index (ODI) score | Pain-related disability was assessed using the ODI, a 10-item measure of low back pain-related disability that evaluates the current effect of a patient's low back pain on various aspects of daily living. ODI scores range from 0 to 100, with higher scores indicating greater disability. | 12 weeks |