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Peer Support Pain Self-Management for Musculoskeletal Pain (CONNECT Trial)

N/A

Recruiting

Led By Mary Driscoll, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain on at least half of the days of the prior six months

Moderate-Severe musculoskeletal pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post baseline

Awards & highlights

CONNECT Trial Summary

This trial will test an 8-week home-based pain self-management intervention for women Veterans with chronic musculoskeletal pain. The intervention will be single-arm, meaning all eligible and interested women will receive it. The primary outcome will be post-treatment and long-term follow-up retention rates.

Who is the study for?

This trial is for women veterans with moderate to severe musculoskeletal pain, who have experienced pain on most days in the past six months. Participants must be receiving care at specified VA healthcare systems, own a cell phone, and be cleared by their provider. Those with life-threatening conditions, sensory deficits affecting calls, upcoming surgeries or certain mental health conditions cannot join.Check my eligibility

What is being tested?

Project CONNECT is being tested; it's an 8-week home-based program where paired participants support each other through text messages and weekly calls to manage chronic pain using coping skills, activity goals setting, and a walking program. All eligible women will receive this intervention without comparison groups.See study design

What are the potential side effects?

Since Project CONNECT involves peer support and self-management techniques rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience emotional discomfort or stress while engaging in the activities.

CONNECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have experienced pain on most days in the last six months.

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I experience moderate to severe joint or muscle pain.

CONNECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility: Long-term Retention

Feasibility: Retention

Secondary outcome measures

Acceptability: Peer Matching

Acceptability: Satisfaction & Credibility

Exploratory: Long-term Responder Analysis

+4 more

CONNECT Trial Design

1Treatment groups

Experimental Treatment

Group I: Pilot Arm: Project CONNECTExperimental Treatment1 Intervention

8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,384 Total Patients Enrolled

14 Trials studying Musculoskeletal Pain

8,521 Patients Enrolled for Musculoskeletal Pain

VA Connecticut Healthcare SystemFED

81 Previous Clinical Trials

6,665 Total Patients Enrolled

Yale UniversityOTHER

1,851 Previous Clinical Trials

2,738,168 Total Patients Enrolled

1 Trials studying Musculoskeletal Pain

330 Patients Enrolled for Musculoskeletal Pain

Media Library

Project CONNECT Clinical Trial Eligibility Overview. Trial Name: NCT04229134 — N/A

Musculoskeletal Pain Research Study Groups: Pilot Arm: Project CONNECT

Musculoskeletal Pain Clinical Trial 2023: Project CONNECT Highlights & Side Effects. Trial Name: NCT04229134 — N/A

Project CONNECT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04229134 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this experiment?

"The primary endpoint of this clinical investigation, which will be observed during a 6 month post-baseline period is Retention Feasibility. Secondary endpoints include Diary Completion Rates (with 95% confidence intervals compared to other Veteran behavioral pain trials that have an 85% completion rate), Dyad Connection (rates assessed relative to 80%, similar to Reciprocal Peer Support interventions) and Responder Analysis (% of subjects with clinically significant reductions in pain intensity/interference & depression as per PHQ-8)."

Answered by AI

What is the current enrolment number for this investigation?

"Affirmative. According to the details hosted on clinicaltrials.gov, this medical trial is actively searching for participants. The study was initially posted on May 5th 2021 and most recently updated on May 5th 2022. 45 patients are needed across a single site of enrolment."

Answered by AI

Are any new participants being accepted into this research endeavor?

"Affirmative. The information found on clinicaltrials.gov attests to this medical trial currently recruiting patients, which was initially posted in May 2021 and last updated the same month of 2022. This study necessitates 45 individuals from a single center for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)

2021. "Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04229134.