NCT02231957

Brief Summary

There are a growing number of adolescents with chronic medical conditions in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination is also recommended for certain high-risk patients. Limited studies suggest that vaccination coverage of this population remains sub-optimal. Text message vaccine reminder/recall has been shown to be effective in increasing uptake of select pediatric and adolescents vaccines, but has yet to be examined among patients with chronic medical conditions who may also face unique barriers to vaccination. This intervention aims to implement and evaluate the use of text message vaccine reminders among urban low-income minority adolescents with chronic medical conditions. This investigator-initiated study is supported in part by a grant from the Pfizer Medical Education Group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration 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

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

August 15, 2014

Last Update Submit

January 27, 2017

Conditions

Vaccination

Outcome Measures

Primary Outcomes (1)

  • Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)

    12 weeks after intervention start

Secondary Outcomes (5)

  • Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)

    4 weeks after intervention start

  • Percentage of eligible subjects who received HPV1, influenza, and/or pneumococcal vaccine(s)

    24 weeks after intervention start

  • Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination

    4 weeks after intervention start

  • Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination

    12 weeks after intervention start

  • Percentage of eligible subjects with missed opportunities for HPV1, influenza, and/or pneumococcal vaccination

    24 weeks after intervention start

Study Arms (2)

educational text message reminders

EXPERIMENTAL

receipt of education-embedded text message vaccine reminders

Other: educational text message reminders

conventional text message reminders

ACTIVE COMPARATOR

receipt of conventional text message vaccine reminders

Other: conventional text message reminders

Interventions

educational text message remindersOTHER
Also known as: educational text message vaccine reminders, education-embedded text message vaccine reminders
educational text message reminders
conventional text message remindersOTHER
Also known as: conventional text message vaccine reminders
conventional text message reminders

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent with
  • adolescent aged 11-17 years;
  • adolescent with ≥1 chronic medical condition;
  • adolescent with clinic visit in last 12 months;
  • cell phone number listed in hospital registration system

You may not qualify if:

  • Parent who:
  • does not speak English or Spanish;
  • is unwilling to receive text message vaccine reminders;
  • anticipates moving from area in coming 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork-Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Hofstetter AM, Barrett A, Camargo S, Rosenthal SL, Stockwell MS. Text message reminders for vaccination of adolescents with chronic medical conditions: A randomized clinical trial. Vaccine. 2017 Aug 16;35(35 Pt B):4554-4560. doi: 10.1016/j.vaccine.2017.07.022. Epub 2017 Jul 21.

    PMID: 28736201DERIVED

Study Officials

  • Annika M Hofstetter, MD, PhD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

August 15, 2014

First Posted

September 4, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

January 1, 2017

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

US(1)