NCT05814315

Brief Summary

The investigators have created an online peer support platform for chronic pain patients on opioid medications. This platform provides peer support and online mental health counselor run support groups to help participants manage pain and not abuse opioid medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

March 31, 2023

Last Update Submit

April 13, 2023

Conditions

Medication CompliancePain

Outcome Measures

Primary Outcomes (1)

  • Generalized Anxiety Disorder scale 7 scores

    Anxiety levels

    12 weeks

Secondary Outcomes (2)

  • Beck Depression Inventory scores

    12 weeks

  • Current Opioid Misuse Measure scores

    12 weeks

Study Arms (2)

HOPE Intervention

EXPERIMENTAL

These participants will have peer support and online support groups.

Behavioral: HOPE Intervention

Control

NO INTERVENTION

The control will not have any support provided.

Interventions

HOPE InterventionBEHAVIORAL

Participants used the Health Checkins Platform for 12 weeks for emotional support and to obtain pain management tools

HOPE Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ElevateU

Corona del Mar, California, 92625-1243, United States

Location

MeSH Terms

Conditions

Medication AdherencePain

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 14, 2023

Study Start

May 1, 2022

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)