I-SIGHT: Interactive Study to Increase Glaucoma Adherence to Treatment

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00794170
• Collaborator: (none)
• Enrollment: 312
• Locations: 2
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 156
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Behavioral: Telephone and Print based intervention	N/A

Detailed Description

The intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen. The intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients. We evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 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.	Behavioral: Telephone and Print based intervention; Thiss intervention consisted of tailored phone calls and follow-up mailings.
No Intervention: Usual care The control group received usual care at each clinical site and interacted with study personnel only for data collection.

Outcome Measures

Primary Outcome Measures

1. Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes) [Baseline and 12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition

• Be between the ages of 18-80

• Be Caucasian or African American

• Possess a telephone (home telephone or cellular phone)

• Speak and understand English

• Be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year

• Be prescribed daily doses of topical treatments for at least one year

• Be able to read or have someone who can help the participant with reading written materials that we give to the participant

Exclusion Criteria:

• Having eye surgery within 3 months of baseline interview and enrollment

• Being legally blind (20/200 or worse)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta VA Medical Center	Atlanta	Georgia	United States	30033
2	Grady Health System	Atlanta	Georgia	United States	30303

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Karen Glanz, PhD, MPH, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen Glanz, MD, Adjunct Professor of Public Health, Emory University
• ClinicalTrials.gov Identifier: NCT00794170
• Other Study ID Numbers: IRB00001335; R01EY016997; I-SIGHT
• First Posted: Nov 19, 2008
• Last Update Posted: Jun 9, 2014
• Last Verified: May 1, 2014

• Keywords provided by Karen Glanz, MD, Adjunct Professor of Public Health, Emory University: Treatment Compliance
• Additional relevant MeSH terms: Glaucoma

Study Results

Participant Flow

Arm/Group Title	Telephone and Print Based Intervention	Usual Care
Arm/Group Description	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.	The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
Period Title: Overall Study
STARTED	157	155
COMPLETED	150	152
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Telephone and Print Based Intervention	Usual Care	Total
Arm/Group Description	This was a tailored phone call followed up by print materials.	control	Total of all reporting groups
Overall Participants	157	155	312
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	91 58%	95 61.3%	186 59.6%
>=65 years	66 42%	60 38.7%	126 40.4%
Sex: Female, Male (Count of Participants)
Female	59 37.6%	58 37.4%	117 37.5%
Male	98 62.4%	97 62.6%	195 62.5%
Region of Enrollment (participants) [Number]
United States	157 100%	155 100%	312 100%

Outcome Measures

1. Primary Outcome

Title	Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Telephone and Print Intervention	Usual Care
Arm/Group Description	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.	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.
Measure Participants	157	155
Number [participants]	150 95.5%	152 98.1%

Adverse Events

Arm/Group Title	Telephone and Print Based Intervention		Usual Care
Arm/Group Description
All Cause Mortality
	Telephone and Print Based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Telephone and Print Based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/155 (0%)
Other (Not Including Serious) Adverse Events
	Telephone and Print Based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/155 (0%)

Limitations/Caveats

There may have been a selection bias that contributed to a placebo effect in the control group. The "control" patients may have already been motivated to seek knowledge or involvement in management of glaucoma.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.