(TVHST2DM): Effects of Use of a Connected Pillbox On Medication Adherence

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02593032
• Collaborator: TowerView Health (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 31.6
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Medication adherence is defined as the extent to which a patient takes his or her medication as prescribed by their healthcare provider. One third to one half of all patients in the United States do not take their medication as directed, resulting in nearly $100B in avoidable hospital costs per year. Recent efforts to improve medication adherence in patients with multiple comorbidities have turned to case management and disease management programs. Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits and outreach. These devices enable frequent monitoring and intervention but can also generate large volumes of data that can be difficult for care teams to manage. The present study explores the use of one such device- a technology-enabled, connected pillbox. Given the continued emphasis on bending the cost curve in US healthcare, clinical validation of tools that may improve the management of costly chronic diseases, such as diabetes, is essential.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Hypertension; Hyperlipidemia	Device: Pre-filled trays	N/A

Detailed Description

Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells. Using this information, TowerView Health system is able to send automated text messages or phone reminders to patients to take forgotten or ignored medication doses. Medication adherence data from deployed pillboxes populates a software platform, which a research coordinator can access.

Patients who miss 3 consecutive doses or 5 doses out of 12 over a 4-day period trigger an alert for the study research coordinator who can contact the patient via phone call. The research coordinator follows a scripted motivational interview in his or her outreach to determine the etiology of non-adherence. Patients reporting worrisome symptoms will be instructed to contact their provider directly and/or go to the emergency room for immediate attention. The investigator acknowledges that the current study actually involves multiple interventions: 1. The pre-filled medication trays are provided by a pharmacist, which overcomes medication access issues as well as the inconvenience of manually organizing medications. 2. The electronic pillbox, which monitors adherence that triggers text message or phone reminders in instances where patients forget or ignore medication doses 3. Research coordinator alerts, which trigger outreach events that employ a motivational interview in order to improve patient adherence.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Study On The Effect of Combined Use of a Connected Pillbox, Pre-filled Medication Trays, Automated Text Message/Phone Call Reminds, On Medication Adherence in Patients With Type II Diabetes Mellitus, Hypertension or Hyperlipidemia
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Sep 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Randomized Treatment Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule.	Device: Pre-filled trays; Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.
No Intervention: Control Arm Patients in the control arm will receive usual care and can continue using their existing pharmacy.

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With Adherence at Month 6 [6-month interval]

   The primary outcome of interest in the present study is improvement in adherence. We will determine if a multi-modal intervention focused on improving medication adherence among adults who were previously non-adherent results in improved medication adherence over a 6-month interval averaged across months 1 to 6. This will be reported as the percent persistent on therapy at 6 months across the three conditions (diabetes, HTN, hyperlipidemia)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:• Insurance and pharmacy coverage with Independence Blue Cross (IBC); 18 years or older; Current diagnosis of Type II Diabetes Mellitus, Hypertension or Hyperlipidemia and taking 5 or more medications; Less than 80% medication adherence; Able to communicate in English; Willing to give informed consent, receive recruitment (invitation)letter from IBC

Exclusion Criteria: Known alcohol or illicit drug abuse; Significant cognitive impairment at baseline as defined by the Animal Naming Screening Tool; Residence in a care facility that provides medication on schedule; Unwilling to use TowerView Health's connected pillbox and accompanying medication trays; Any active medical or psychiatric diagnosis that, based on the clinical assessment of the research team, would prevent the study participant from completing the trial such as: markedly shortened life expectancy (e.g. diagnosis of metastatic cancer, end stage renal disease on dialysis, New York Heart Association (NYHA) Class III or IV heart failure, active psychosis or suicidal ideation, etc.) or dexterity/motor impairments (e.g. severe arthritis, neuromuscular disorders, etc); and Lack a mobile or land line phone.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• TowerView Health

Investigators

• Principal Investigator: Nalaka S Gooneratne, MD, University of Pennsylvannia

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 22, 2014

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02593032
• Other Study ID Numbers: 821737
• First Posted: Oct 30, 2015
• Last Update Posted: Aug 4, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Pennsylvania: hemoglobin A1c protein, human > 7.5
• Additional relevant MeSH terms: Hypertension; Diabetes Mellitus; Hyperlipidemias; Hyperlipoproteinemias

Study Results

Participant Flow

Arm/Group Title	Randomized Treatment	Control Arm
Arm/Group Description	Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.	Patients in the control arm will receive usual care and can continue using their existing pharmacy.
Period Title: Overall Study
STARTED	17	33
COMPLETED	17	33
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Randomized Treatment	Control Arm	Total
Arm/Group Description	Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.	Patients in the control arm will receive usual care and can continue using their existing pharmacy.	Total of all reporting groups
Overall Participants	17	33	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (3.2)	65 (3.4)	64 (3.3)
Sex: Female, Male (Count of Participants)
Female	11 64.7%	25 75.8%	36 72%
Male	6 35.3%	8 24.2%	14 28%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 64.7%	24 72.7%	35 70%
White	6 35.3%	9 27.3%	15 30%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Self-reported adherence status to all medications (Number with self-reported low adherence) [Number]
Number [Number with self-reported low adherence]	15	31	46

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With Adherence at Month 6
Description	The primary outcome of interest in the present study is improvement in adherence. We will determine if a multi-modal intervention focused on improving medication adherence among adults who were previously non-adherent results in improved medication adherence over a 6-month interval averaged across months 1 to 6. This will be reported as the percent persistent on therapy at 6 months across the three conditions (diabetes, HTN, hyperlipidemia)
Time Frame	6-month interval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Treatment	Control Arm
Arm/Group Description	Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.	Patients in the control arm will receive usual care and can continue using their existing pharmacy.
Measure Participants	17	33
Number [percent persistent on therapy]	91	40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Randomized Treatment, Control Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	This is the calculated p-value, not a threshold.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Randomized Treatment		Control Arm
Arm/Group Description	Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.		Patients in the control arm will receive usual care and can continue using their existing pharmacy.
All Cause Mortality
	Randomized Treatment		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/33 (0%)
Serious Adverse Events
	Randomized Treatment		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Randomized Treatment		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/33 (0%)

Limitations/Caveats

Early termination due to funding constraints, leading to a smaller sample size than originally proposed.

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.