The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence

Medication Adherence Clinical Trial

Official title: The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence: A Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The investigators hypothesize that providing subjects on a once-a-day hypertension medication with GlowCaps ConnectTM will lead to an improvement in their medication adherence. The investigators propose to conduct a 6-month randomized control trial to assess the effect of the GlowCaps Connect™ system on the enhancement of hypertension medication adherence among subjects with a diagnosis of hypertension recruited from the greater Boston area. 130 subjects will be enrolled. Subjects will be randomized into either the control group or into one of two intervention groups.

Clinical Trial Description

Participants will use the GlowCap system for 6 months.

Group 1

• The GlowCap bottle provided for subjects in this group will passively track medication adherence over the course of the study

• The pill cap will collect data, but will not provide any visual or auditory alerts

• An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.

Group 2

• Subjects in this group will be given daily visual, auditory, and phone call reminders to take their medication via the GlowCap system if they fail to take their hypertension medication at the scheduled dose time

• An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.

• Subjects will receive Weekly and Monthly Progress Reports by email and mail, respectively. Reports will include information about medication adherence and target goals. If a subject does not opt-out, Monthly Progress Reports will also be sent to the subject's primary care physician (PCP)

• If the subject chooses, a friend or family member will receive a Weekly Progress Report by email

• If the subject chooses, he/she will receive prompts (via automated telephone call twice a month) to refill his/her prescription

• Subjects demonstrating consistent low adherence to medication will receive additional support in the form of calls from Vitality reminding them to take the medication.

Group 3

• Subjects in this group will be given daily visual, auditory, and phone call reminders to take their medication via the GlowCap system if they fail to take their hypertension medication at the scheduled dose time

• An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.

• Subjects will receive Weekly and Monthly Progress Reports by email and mail, respectively. Reports will include information about medication adherence and target goals. If a subject does not opt-out, Monthly Progress Reports will also be sent to the subject's primary care physician (PCP)

• If the subject chooses, a friend or family member will receive a Weekly Progress Report by email

• Subjects will receive financial incentives in the form of a check for meeting a target adherence goal of 80% adherence over each month. The check will be mailed to them at the end of the study.

• If the subjects chooses, he/she will receive prompts (via automated telephone call twice a month) to refill his/her prescription

• Subjects demonstrating consistent low adherence to medication will receive additional support in the form of calls from Vitality reminding them to take the medication and may receive increased financial incentives to meet their target.

Study subjects will attend two study visits, one at the beginning and one at the end of the 6 month period. At these visits they will have their blood pressure recorded and will be asked to complete a survey. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

• NCT number: NCT00985452
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Completion date: August 2010