Trial Outcomes & Findings for Interactive Study to Increase Glaucoma Adherence to Treatment (NCT NCT00794170)

Results Overview

The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

312 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2014-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Telephone and Print Based Intervention The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.	Usual Care The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
Overall Study STARTED	157	155
Overall Study COMPLETED	150	152
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interactive Study to Increase Glaucoma Adherence to Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telephone and Print Based Intervention n=157 Participants This was a tailored phone call followed up by print materials.	Usual Care n=155 Participants control	Total n=312 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	95 Participants n=7 Participants	186 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants	60 Participants n=7 Participants	126 Participants n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	97 Participants n=7 Participants	195 Participants n=5 Participants
Region of Enrollment United States	157 participants n=5 Participants	155 participants n=7 Participants	312 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.

The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.

Outcome measures

Outcome measures
Measure	Telephone and Print Intervention n=157 Participants The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.	Usual Care n=155 Participants The control group receives usual care at each clinical site and interacts with study personnel only for data collection. Both groups receive birthday cards from the study team.
Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)	150 participants	152 participants

Adverse Events

Telephone and Print Based Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Karen Glanz

University of Pennsylvania

Phone: 215-898-0613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place