Trial Outcomes & Findings for eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System (NCT NCT03898349)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

750 participants

Primary outcome timeframe

Post (after 12 weeks of Annie text messaging use)

Results posted on

2023-07-27

Participant Flow

This was not an intent to treat design, therefore UI and AI groups were combined to compare texters and non-texters from each of the groups (and control).

Participant milestones

Participant milestones
Measure	Non-texters Patients who did not receive the automated text messaging system "Annie"	Texters Patients who did receive the automated text messaging system "Annie" Annie text messaging system: Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. Annie text messaging system with Usual implementation: 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
Overall Study STARTED	125	625
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	110	610

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The 30 are those in the 2 arms who were analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Texters n=15 Participants Patients did not receive the automated text messaging system "Annie"	Texters n=15 Participants Patients received the Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.	Total n=30 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 11 • n=5 Participants • The 30 are those in the 2 arms who were analyzed.	62 years STANDARD_DEVIATION 6 • n=7 Participants • The 30 are those in the 2 arms who were analyzed.	62 years STANDARD_DEVIATION 11 • n=5 Participants • The 30 are those in the 2 arms who were analyzed.
Sex: Female, Male Female	1 Participants n=5 Participants • we did not have demographic characteristics for the overall population	1 Participants n=7 Participants • we did not have demographic characteristics for the overall population	2 Participants n=5 Participants • we did not have demographic characteristics for the overall population
Sex: Female, Male Male	14 Participants n=5 Participants • we did not have demographic characteristics for the overall population	14 Participants n=7 Participants • we did not have demographic characteristics for the overall population	28 Participants n=5 Participants • we did not have demographic characteristics for the overall population
Race/Ethnicity, Customized African American or Black	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post (after 12 weeks of Annie text messaging use)

Population: This was not an intent to treat design, therefore UI and AI groups were combined to compare texters and non-texters from each of the groups (and control).

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.

Outcome measures

Outcome measures
Measure	Non-texters n=15 Participants Patients who did not receive Annie text messages Annie text messaging system: Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. Annie text messaging system with Usual implementation: 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 n=15 Participants Patients who received Annie text messages Annie text messaging system: Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages. Annie text messaging system with Augmented implementation: 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
Perception of HCV Treatment Success	8 Participants	13 Participants

Adverse Events

Non-texters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Texters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vera Yakovchenko

VA

Phone: 7816873374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place