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Trial Outcomes & Findings for Study of Reminding to Improve Medication Adherence in Heart Failure (NCT NCT01463267)

NCT ID: NCT01463267

Last Updated: 2020-11-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

28 days

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure
Device 2 Passive
Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Device 2 Active
Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Active
Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Passive
Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Overall Study
STARTED
15
15
15
15
Overall Study
COMPLETED
14
15
13
13
Overall Study
NOT COMPLETED
1
0
2
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Reminding to Improve Medication Adherence in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Device 2 Passive
n=14 Participants
Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Device 2 Active
n=15 Participants
Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Active
n=13 Participants
Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Passive
n=13 Participants
Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Total
n=55 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
21 Participants
n=21 Participants
Age, Categorical
>=65 years
9 Participants
n=5 Participants
9 Participants
n=7 Participants
8 Participants
n=5 Participants
8 Participants
n=4 Participants
34 Participants
n=21 Participants
Age, Continuous
69 years
STANDARD_DEVIATION 10.6 • n=5 Participants
69 years
STANDARD_DEVIATION 10.6 • n=7 Participants
69.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
69.6 years
STANDARD_DEVIATION 11.3 • n=4 Participants
69.3 years
STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
11 Participants
n=21 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
12 Participants
n=7 Participants
10 Participants
n=5 Participants
11 Participants
n=4 Participants
44 Participants
n=21 Participants
Region of Enrollment
United States
14 Participants
n=5 Participants
15 Participants
n=7 Participants
13 Participants
n=5 Participants
13 Participants
n=4 Participants
55 Participants
n=21 Participants
Education
14 participants
n=5 Participants
15 participants
n=7 Participants
13 participants
n=5 Participants
13 participants
n=4 Participants
55 participants
n=21 Participants

PRIMARY outcome

Timeframe: 28 days

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.

Outcome measures

Outcome measures
Measure
Device 2 Passive
n=14 Participants
Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Device 2 Active
n=15 Participants
Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Active
n=13 Participants
Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Passive
n=13 Participants
Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Patient Acceptance
33.4 units on a scale
Standard Deviation 11
33.4 units on a scale
Standard Deviation 12
48.7 units on a scale
Standard Deviation 11
48.7 units on a scale
Standard Deviation 12

PRIMARY outcome

Timeframe: 28 days

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

Outcome measures

Outcome measures
Measure
Device 2 Passive
n=14 Participants
Device 2 will NOT remind patients to take medications Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Device 2 Active
n=15 Participants
Device 2 will remind patients to take medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Active
n=13 Participants
Device 1 will remind patients to take their medications iPhone or pillbox: People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
Device 1 Passive
n=13 Participants
Device 1 will NOT remind patients to take medications. Non-reminding: As a comparison, the devices will collect medication taking information without providing reminders.
Medication Adherence
76 percentage of medication taken
Standard Deviation 33
84 percentage of medication taken
Standard Deviation 32
73 percentage of medication taken
Standard Deviation 39
79 percentage of medication taken
Standard Deviation 33

Adverse Events

Device 2 Passive

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Device 2 Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Device 1 Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Device 1 Passive

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joel Hughes

Kent State University

Phone: 3306727721

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place