The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program

NCT03159247 | Completed

• 2 other identifiers: HUM001126141K23EY025320-01A1
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test the impact of two personalized technology based programs that may help improve adherence to glaucoma medications.

Conditions

Medication Adherence; Glaucoma

Keywords

education; counseling; motivational interviewing; tailoring

Outcome Measures

Primary Outcomes (1)

• Electronically monitored glaucoma medication adherence

  electronic medication monitoring

  22 months

Secondary Outcomes (5)

• Proportion of days covered with medication

  22 months

• Change in self-reported medication adherence

  22 months

• Change in eye drop instillation technique

  4 months elapsed between 4 month and 8 month site visits

• Change in Intra-ocular Pressure

  22 months

• Change in Intra-ocular Pressure Fluctuation

  22 months

Study Arms (1)

eyeGuide

EXPERIMENTAL

Two personalized eHealth interventions aimed to improve glaucoma medication adherence.

Behavioral: eyeGuide

Interventions

eyeGuide BEHAVIORAL

The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.

eyeGuide

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of glaucoma, glaucoma suspect or ocular hypertension
• Taking ≥ 1 glaucoma medication
• Age ≥ 40 years
• Non-adherent to glaucoma medications by both self-report and three months of electronic medication monitoring (adherence ≤ 80%)

You may not qualify if:

• Cognitive impairment
• Severe mental illness
• Do not administer own glaucoma medications
• Do not speak English

Sponsors & Collaborators

• University of Michigan: lead
• National Eye Institute (NEI): collaborator
• Research to Prevent Blindness: collaborator
• Henry Ford Health System: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (38)

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  BACKGROUND

• Schneider KJ, Hollenhorst CN, Valicevic AN, Niziol LM, Heisler M, Musch DC, Cain SM, Newman-Casey PA. Impact of the Support, Educate, Empower Personalized Glaucoma Coaching Program Pilot Study on Eye Drop Instillation Technique and Self-Efficacy. Ophthalmol Glaucoma. 2021 Jan-Feb;4(1):42-50. doi: 10.1016/j.ogla.2020.08.003. Epub 2020 Aug 8.

  PMID: 32781286 DERIVED

• Sanchez FG, Mansberger SL, Newman-Casey PA. Predicting Adherence With the Glaucoma Treatment Compliance Assessment Tool. J Glaucoma. 2020 Nov;29(11):1017-1024. doi: 10.1097/IJG.0000000000001616.

  PMID: 32740508 DERIVED

• Newman-Casey PA, Niziol LM, Mackenzie CK, Resnicow K, Lee PP, Musch DC, Heisler M. Personalized behavior change program for glaucoma patients with poor adherence: a pilot interventional cohort study with a pre-post design. Pilot Feasibility Stud. 2018 Jul 23;4:128. doi: 10.1186/s40814-018-0320-6. eCollection 2018.

  PMID: 30062043 DERIVED

MeSH Terms

Conditions

Medication Adherence; Glaucoma

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Ocular Hypertension; Eye Diseases

Study Officials

• Paula A Newman-Casey, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology and Visual Sciences

Model Details: This is a single group prospective behavioral intervention with a pre-post design. Adherence will be measured for three months at baseline, for an additional one month after an automated reminder system is initiated, for an additional six months during a personalized behavior change intervention and then for one year after the intervention.

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 18, 2017
• Study Start: January 12, 2017
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)