Development and Implementation of an Educational Program to Enhance Adherence to Glaucoma Treatment

NCT04245163 | Unknown

• 1 other identifier: CUT15012018MA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of an educational intervention program in order to improve medication adherence in glaucoma patients. Half of the participants will receive the educational program while the other half will receive normal care and a leaflet about glaucoma.

Conditions

Glaucoma

Keywords

medication adherence; education*; intervention

Outcome Measures

Primary Outcomes (1)

• Change to the Glaucoma Treatment Compliance Assessment Tool (GTCAT-28)

  Easy and quick questionnaire specially designed for patients with glaucoma. It contains 27 statements with 5-interval Likert-type scale response (eg, 1- disagree a lot, 5-agree a lot) and 1 open ended question for assessing the knowledge, the Health Belief Model components (Barriers, Benefits, Cues to Action, Self-efficacy, Severity, Susceptibility), the patient-physician relationship, and their physical and mental health. The correct answers range from 0 to 27, with the highest score indicating more adherence to the treatment. The purpose is to assess the change between several time points (e.g. before the intervention, after the intervention-same day, one month after the intervention and three months after the intervention). The reason is, firstly, to assess if there is a change between T0 and T1 and secondly to assess if the effect of the intervention (as indicated by the change in the GTCAT) remain for a longer period of time.

  T0: before intervention (4-12 months before), T1: immediately after the intervention (same day), T2: One month after the intervention, T3: Three months after the intervention

Secondary Outcomes (2)

• European Health Literacy Survey Questionnaire (HLS-EU-Q6)

  T0: before the intervention (4-12 months before)

• Change to the Glaucoma Medication Self-Efficacy Questionnaire (GMSEQ-16)

  T0: before the intervention (4-12 months before), T1: immediately after the intervention (same day), T2: One month after the intervention, T3: Three months after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will be invited for the training program.

Behavioral: Educational program

Control Group

NO INTERVENTION

Participants who will be randomized in control group will receive normal care (the care that each clinic provides to the patients) and will be given an educational material (without telling them that they are in the control group). They will receive, however, the education class later (at the end of the study).

Interventions

Educational program BEHAVIORAL

The intervention program will include 3 phases. At phase 1 a presentation on Microsoft PowerPoint in order to increase the general knowledge about glaucoma. At phase 2 a video and a one on one teaching to develop skills of administering the eye drops in a correct and systematic way. At phase 3, a discussion in order to identify cues to action that can easily be adopted by the patient in his/her daily routine, (such as, how to remember to put in drops) will take place.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years of age
• Ability to read and understand Greek
• Able to give informed consent
• Diagnosis of glaucoma or ocular hypertension, requiring treatment with hypotensive eye drops (at least one time per day).
• Patients who scored less than 80% adherent on GTCAT

You may not qualify if:

• None

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Pantheon Eye Center

Limassol, 3076, Cyprus

Location

MeSH Terms

Conditions

Glaucoma; Medication Adherence

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maria Achilleos, PhDcandidate

CONTACT

+357 95119123; maria_ach_@hotmail.com

Evridiki Papastavrou, Professor

CONTACT

+357 25 002021; e.papastavrou@cut.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants who will be randomized in control group will receive normal care (the care that each clinic provides to the patients) and will be given an educational material (without telling them that they are in the control group). They will receive, however, the education class later (at the end of the study). Participants in the intervention group will be invited for the training program

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: June 10, 2021
• Primary Completion: July 10, 2021
• Study Completion: September 1, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)