Trial Outcomes & Findings for Connected Healthcare for Individuals Living at Home With Chronic Conditions (NCT NCT04339296)
NCT ID: NCT04339296
Last Updated: 2020-10-20
Results Overview
The intervention group adherence recording was obtained from Catalyst's AdhereNet platform. The spencer adherence was defined as percentage of medications dispensed from the system at the prescribed time. The user had a two-hour window to remove the medication pouch. If dispensed, they are given a score of 100 for the particular medication time. If not removed, the user was considered non-adherent and given a score of 0. Weekly medication adherence was calculated by taking the seven day average of daily dispensing adherence values. In the control group, adherence was measured through monthly medication calendars completed by participants. Each participant received customized calendars based on their medications timings along with instruction sheet for tracking their medications. Participants were required to mark "X" on the calendar on the day and time they missed taking their medication(s). Average adherence (weekly) was used as a primary outcome measure.
COMPLETED
NA
91 participants
26 weeks
2020-10-20
Participant Flow
Study participants were recruited from a Family Care Clinic during the period of June to October 2019. The clinic mailed invitation letters to potentially eligible participants. Also, potentially eligible participants with scheduled appointments at the clinic were flagged by clinic staff so they could be informed and directed to research staff.
A total of 91 participants were assessed for eligibility and 50 were randomized into the two groups; 24 allocated to intervention and 26 allocated to control. A total of 16 spencer participants and 17 control participants completed the study. The study dropout rate was 33% (n=8) and 35% (n=9) in the intervention and control group, respectively.
Participant milestones
| Measure |
Intervention Group
Intervention group included medication management with Spencer.
Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition specific questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.
|
Control Group
The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
Completed Baseline
|
23
|
25
|
|
Overall Study
Received Allocated Intervention
|
21
|
24
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Intervention Group
Intervention group included medication management with Spencer.
Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition specific questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.
|
Control Group
The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
|
|---|---|---|
|
Overall Study
Refuse to participate after allocation
|
1
|
1
|
|
Overall Study
Withdrew after completion of baseline
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Discontinued intervention
|
5
|
3
|
Baseline Characteristics
One intervention participant preferred not to disclose this information.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=23 Participants
Intervention group included medication management with Spencer.
Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition specific questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.
|
Control Group
n=25 Participants
The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.96 Years
STANDARD_DEVIATION 7.86 • n=23 Participants
|
59.92 Years
STANDARD_DEVIATION 5.93 • n=25 Participants
|
61.94 Years
STANDARD_DEVIATION 6.90 • n=48 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=23 Participants
|
17 Participants
n=25 Participants
|
33 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=23 Participants
|
8 Participants
n=25 Participants
|
15 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
21 Participants
n=23 Participants
|
24 Participants
n=25 Participants
|
45 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
1 Participants
n=23 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
South East Asian
|
1 Participants
n=23 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=48 Participants
|
|
Living Arrangement
Alone in residence
|
8 Participants
n=23 Participants
|
12 Participants
n=25 Participants
|
20 Participants
n=48 Participants
|
|
Living Arrangement
With Spouse
|
8 Participants
n=23 Participants
|
5 Participants
n=25 Participants
|
13 Participants
n=48 Participants
|
|
Living Arrangement
With family member(s) other than spouse
|
4 Participants
n=23 Participants
|
3 Participants
n=25 Participants
|
7 Participants
n=48 Participants
|
|
Living Arrangement
Other
|
3 Participants
n=23 Participants
|
5 Participants
n=25 Participants
|
8 Participants
n=48 Participants
|
|
Education
Less than High School Diploma
|
5 Participants
n=22 Participants • One intervention participant preferred not to disclose this information.
|
7 Participants
n=25 Participants • One intervention participant preferred not to disclose this information.
|
12 Participants
n=47 Participants • One intervention participant preferred not to disclose this information.
|
|
Education
High School Diploma
|
4 Participants
n=22 Participants • One intervention participant preferred not to disclose this information.
|
6 Participants
n=25 Participants • One intervention participant preferred not to disclose this information.
|
10 Participants
n=47 Participants • One intervention participant preferred not to disclose this information.
|
|
Education
Some College, no degree
|
11 Participants
n=22 Participants • One intervention participant preferred not to disclose this information.
|
7 Participants
n=25 Participants • One intervention participant preferred not to disclose this information.
|
18 Participants
n=47 Participants • One intervention participant preferred not to disclose this information.
|
|
Education
Bachelor's Degree
|
2 Participants
n=22 Participants • One intervention participant preferred not to disclose this information.
|
5 Participants
n=25 Participants • One intervention participant preferred not to disclose this information.
|
7 Participants
n=47 Participants • One intervention participant preferred not to disclose this information.
|
|
Employment Status
Employed (Full Time)
|
0 Participants
n=23 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=48 Participants
|
|
Employment Status
Employed (Part Time)
|
1 Participants
n=23 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=48 Participants
|
|
Employment Status
Unemployed
|
1 Participants
n=23 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=48 Participants
|
|
Employment Status
Retired
|
11 Participants
n=23 Participants
|
6 Participants
n=25 Participants
|
17 Participants
n=48 Participants
|
|
Employment Status
Disabled
|
10 Participants
n=23 Participants
|
16 Participants
n=25 Participants
|
26 Participants
n=48 Participants
|
|
Annual Income
< $21,000
|
9 Participants
n=23 Participants • One control participant preferred not to disclose this information.
|
16 Participants
n=24 Participants • One control participant preferred not to disclose this information.
|
25 Participants
n=47 Participants • One control participant preferred not to disclose this information.
|
|
Annual Income
$21,000 - $40,000
|
9 Participants
n=23 Participants • One control participant preferred not to disclose this information.
|
6 Participants
n=24 Participants • One control participant preferred not to disclose this information.
|
15 Participants
n=47 Participants • One control participant preferred not to disclose this information.
|
|
Annual Income
> $41,000
|
5 Participants
n=23 Participants • One control participant preferred not to disclose this information.
|
2 Participants
n=24 Participants • One control participant preferred not to disclose this information.
|
7 Participants
n=47 Participants • One control participant preferred not to disclose this information.
|
|
Chronic Health Conditions
|
4.48 Chonic conditions
STANDARD_DEVIATION 2.19 • n=23 Participants
|
4.20 Chonic conditions
STANDARD_DEVIATION 1.98 • n=25 Participants
|
4.34 Chonic conditions
STANDARD_DEVIATION 2.09 • n=48 Participants
|
|
Prescribed Medications
|
9.39 Prescribed medications
STANDARD_DEVIATION 3.73 • n=23 Participants
|
10.12 Prescribed medications
STANDARD_DEVIATION 4.76 • n=25 Participants
|
9.76 Prescribed medications
STANDARD_DEVIATION 4.25 • n=48 Participants
|
|
Over-the-counter (OTC) Medications
|
1.68 OTC medications
STANDARD_DEVIATION 1.84 • n=23 Participants
|
2.12 OTC medications
STANDARD_DEVIATION 2.74 • n=25 Participants
|
1.90 OTC medications
STANDARD_DEVIATION 2.29 • n=48 Participants
|
|
Help Taking Medication
Yes
|
5 Participants
n=23 Participants
|
4 Participants
n=25 Participants
|
9 Participants
n=48 Participants
|
|
Help Taking Medication
No
|
18 Participants
n=23 Participants
|
21 Participants
n=25 Participants
|
39 Participants
n=48 Participants
|
|
Medication Management Method
Blister Pack
|
5 Participants
n=19 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
12 Participants
n=23 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
17 Participants
n=42 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
|
Medication Management Method
Pill Organizers
|
9 Participants
n=19 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
4 Participants
n=23 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
13 Participants
n=42 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
|
Medication Management Method
None (pill containers)
|
2 Participants
n=19 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
6 Participants
n=23 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
8 Participants
n=42 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
|
Medication Management Method
Other
|
3 Participants
n=19 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
1 Participants
n=23 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
4 Participants
n=42 Participants • Some participants in both groups didn't know about their medication management method and response wasn't recorded.
|
|
Medication Times/Day
|
2.91 Number of medication times per day
STANDARD_DEVIATION 0.92 • n=23 Participants
|
2.87 Number of medication times per day
STANDARD_DEVIATION 1.11 • n=25 Participants
|
2.89 Number of medication times per day
STANDARD_DEVIATION 1.02 • n=48 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Intention-to-treat analysis was utilized. From the 21 intervention participants that started using spencer, adherence data was only collected from 20 participants. One participants withdrew right after receiving spencer and no data was collected. From 24 control participants, no adherence data was collected from two lost to follow participants.
The intervention group adherence recording was obtained from Catalyst's AdhereNet platform. The spencer adherence was defined as percentage of medications dispensed from the system at the prescribed time. The user had a two-hour window to remove the medication pouch. If dispensed, they are given a score of 100 for the particular medication time. If not removed, the user was considered non-adherent and given a score of 0. Weekly medication adherence was calculated by taking the seven day average of daily dispensing adherence values. In the control group, adherence was measured through monthly medication calendars completed by participants. Each participant received customized calendars based on their medications timings along with instruction sheet for tracking their medications. Participants were required to mark "X" on the calendar on the day and time they missed taking their medication(s). Average adherence (weekly) was used as a primary outcome measure.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Intervention group included medication management with Spencer.
Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition specific questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.
|
Control Group
n=22 Participants
The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
|
|---|---|---|
|
Recorded Medication Adherence
|
98.35 percentage of medication adherence
Standard Deviation 2.15
|
91.17 percentage of medication adherence
Standard Deviation 9.76
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: Paired sample t-test completed was used at baseline (pretest) and six-month (posttest) for intervention and control group. In the intervention group, adherence data was collected from 16 participants who completed the study. In the control group, 17 participants completed the study but six-month data wasn't collected from two participants.
The within group difference in mean rating scores of self-reported medication adherence. The adherence question asked participants to rate their medication adherence on a scale of 1 (non-adherent) to 10 (adherent).
Outcome measures
| Measure |
Intervention Group
n=16 Participants
Intervention group included medication management with Spencer.
Spencer dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. Spencer allows participants to dispense medications early if they are going to be away from home. The system also displays personalized and health-condition specific questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.
|
Control Group
n=15 Participants
The control group continued to use their current method of medication management, such as blister packs, strip packs, pill organizers and plastic prescription vials.
|
|---|---|---|
|
Self-reported Medication Adherence
Baseline (Pretest)
|
7.63 score on a scale
Standard Deviation 1.63
|
7.20 score on a scale
Standard Deviation 1.74
|
|
Self-reported Medication Adherence
6-month (Posttest)
|
9.13 score on a scale
Standard Deviation 0.81
|
8.27 score on a scale
Standard Deviation 2.09
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research and Evaluation Coordinator
Health Systems Evaluation & Evidence - Alberta Health Services
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place