NCT03898349

Brief Summary

Conduct a rigorous formative evaluation of the initial deployment of the Annie texting system across several pilot test sites and from these findings, develop and test an augmented implementation strategy to facilitate more rapid adoption of Annie across VA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 13, 2019

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

March 20, 2019

Results QC Date

April 11, 2019

Last Update Submit

July 19, 2023

Conditions

Keywords

Automated Text Messaging SystemImplementation scienceHepatitis C

Outcome Measures

Primary Outcomes (1)

  • Perception of HCV Treatment Success

    The primary goal of the automated text messaging system is to improve patient self-management. As such, we measured illness perception and patient activation using a validated instrument adapted for HCV (Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med 2008;6(3):246-252). The item "Feeling that I am failing with my HCV treatment" represents patient perceptions about their ability to take medications as prescribed and reflects concerns about failing HCV treatment.

    Post (after 12 weeks of Annie text messaging use)

Study Arms (2)

Non-Texters

NO INTERVENTION

Patients did not receive the automated text messaging system "Annie"

Texters

ACTIVE COMPARATOR

Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.

Other: Annie text messaging systemOther: Annie text messaging system with Usual implementationOther: Annie text messaging system with Augmented implementation

Interventions

Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.

Texters

Three comparison sites received usual implementation of the automated text messaging system "Annie" only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls

Texters

Four facilities received the automated text messaging system "Annie" and our augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance

Texters

Eligibility Criteria

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

You may qualify if:

  • Starting HCV treatment at a VA clinic
  • Have access/ability to text messaging

You may not qualify if:

  • Not being treating for HCV
  • No access/ability to use a cell phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (2)

  • Yakovchenko V, McInnes DK, Petrakis BA, Gillespie C, Lipschitz JM, McCullough MB, Richardson L, Vetter B, Hogan TP. Implementing Automated Text Messaging for Patient Self-management in the Veterans Health Administration: Qualitative Study Applying the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability Framework. JMIR Mhealth Uhealth. 2021 Nov 15;9(11):e31037. doi: 10.2196/31037.

  • Yakovchenko V, Hogan TP, Houston TK, Richardson L, Lipschitz J, Petrakis BA, Gillespie C, McInnes DK. Automated Text Messaging With Patients in Department of Veterans Affairs Specialty Clinics: Cluster Randomized Trial. J Med Internet Res. 2019 Aug 4;21(8):e14750. doi: 10.2196/14750.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Vera Yakovchenko
Organization
VA

Study Officials

  • Timothy Patrick Hogan, PhD MS BS

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR
  • Christopher Gillespie, PhD MA BS

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR
  • Donald K McInnes, ScD MS BA

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Patients and providers did not know which facilitation group they were in
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: Four facilities were randomized to serve as intervention sites and receive our augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance. An additional three comparison sites received usual implementation of Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls run by the Office of Connected Care. Two control sites did not receive Annie.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

April 2, 2019

Study Start

October 1, 2015

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

July 27, 2023

Results First Posted

December 13, 2019

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations