NCT01463267

Brief Summary

This study is being done to look at how people manage their heart failure. The investigators are testing two medication reminder systems and the investigators want to know which one people like better. The investigators also want to see if they have any effect on ease of managing medication in individuals with heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

September 27, 2011

Results QC Date

October 15, 2020

Last Update Submit

November 5, 2020

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Patient Acceptance

    Patient ratings of their satisfaction with the device, ease of use, and other impressions. A survey was created for this study to assess individuals' evaluations of the device to which they were randomized (see Appendix 1). At the final study session, participants completed the questionnaire about their preference for the device they were assigned. The 14 items were summed into a total score reflecting their ultimate appraisal for the device. The range of possible scores was 14-70. A higher score is greater patient acceptance. Participants rated how much they agreed to each statement from strongly disagree to strongly agree. The statements assess factors such as helpfulness, improving quality of life, and satisfaction.

    28 days

  • Medication Adherence

    The percentage of prescribed medications recorded as taken by the medication reminding device.

    28 days

Study Arms (4)

Device 2 passive

ACTIVE COMPARATOR

Device 2 will NOT remind patients to take medications

Behavioral: Non-reminding

Device 2 active

ACTIVE COMPARATOR

Device 2 will remind patients to take medications

Device: iPhone or pillbox

Device 1 active

ACTIVE COMPARATOR

Device 1 will remind patients to take their medications

Device: iPhone or pillbox

Device 1 Passive

PLACEBO COMPARATOR

Device 1 will NOT remind patients to take medications.

Behavioral: Non-reminding

Interventions

iPhone or pillboxDEVICE

People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.

Device 1 activeDevice 2 active
Non-remindingBEHAVIORAL

As a comparison, the devices will collect medication taking information without providing reminders.

Device 1 PassiveDevice 2 passive

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • documented systolic or diastolic heart failure

You may not qualify if:

  • History of neurological disorder
  • moderate or severe head injury with greater than 10 min loss of consciousness
  • year past or current history of alcohol or drug abuse (defined by DSM-IV criteria)
  • History of learning disorder or developmental disability (defined by DSM-IV criteria)
  • Renal failure requiring dialysis
  • Current home telemonitoring program to assist with HF self-management
  • They do not have a land-line telephone
  • Cardiac surgery \< 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akron City Hospital

Akron, Ohio, 44304, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Joel Hughes
Organization
Kent State University
jhughes1@kent.edu
3306727721

Study Officials

  • Joel W Hughes, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 27, 2011

First Posted

November 1, 2011

Study Start

November 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 27, 2020

Results First Posted

November 27, 2020

Record last verified: 2020-11

Locations

US(1)