Trial Outcomes & Findings for Vascular Lifestyle-Intervention and Screening in Pharmacy (NCT NCT02223793)
NCT ID: NCT02223793
Last Updated: 2020-05-06
Results Overview
The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age). Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.
Recruitment status
UNKNOWN
Study phase
NA
Target enrollment
582 participants
Primary outcome timeframe
Baseline and at 8 weeks
Results posted on
2020-05-06
Participant Flow
Participant milestones
| Measure |
No Information on High Risk Factor Levels But Lifestyle Advice
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
|
No Information on High Risk Factor Levels Nor Lifestyle Advice
In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
|
Information on High Risk Factor Levels and Lifestyle Advice
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
185
|
199
|
198
|
|
Overall Study
COMPLETED
|
168
|
190
|
185
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
13
|
Reasons for withdrawal
| Measure |
No Information on High Risk Factor Levels But Lifestyle Advice
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
|
No Information on High Risk Factor Levels Nor Lifestyle Advice
In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
|
Information on High Risk Factor Levels and Lifestyle Advice
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
|
Overall Study
Moved/studycenter unable to participate
|
4
|
6
|
8
|
Baseline Characteristics
Vascular Lifestyle-Intervention and Screening in Pharmacy
Baseline characteristics by cohort
| Measure |
No Information on High Risk Factor Levels But Lifestyle Advice
n=185 Participants
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
|
No Information on High Risk Factor Levels Nor Lifestyle Advice
n=199 Participants
In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
|
Information on High Risk Factor Levels and Lifestyle Advice
n=198 Participants
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
|
Total
n=582 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
|
|
Age, Categorical
Between 18 and 65 years
|
113 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
368 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
417 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Region of Enrollment
Norway
|
185 participants
n=5 Participants
|
199 participants
n=7 Participants
|
198 participants
n=5 Participants
|
582 participants
n=4 Participants
|
|
Ad hoc risk score
|
5.2 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 8 weeksPopulation: Between groups analysis
The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age). Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.
Outcome measures
| Measure |
No Information on High Risk Factor Levels But Lifestyle Advice
n=185 Participants
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
|
No Information on High Risk Factor Levels Nor Lifestyle Advice
n=199 Participants
In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
|
Information on High Risk Factor Levels and Lifestyle Advice
n=198 Participants
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
|
|---|---|---|---|
|
Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)
|
-0.71 units on a scale
Interval -0.99 to -0.44
|
-0.76 units on a scale
Interval -1.02 to -0.5
|
-0.36 units on a scale
Interval -0.62 to -0.09
|
SECONDARY outcome
Timeframe: At baseline and at 8 weeksPopulation: Difference between three groups.
Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.
Outcome measures
| Measure |
No Information on High Risk Factor Levels But Lifestyle Advice
n=168 Participants
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
|
No Information on High Risk Factor Levels Nor Lifestyle Advice
n=190 Participants
In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
|
Information on High Risk Factor Levels and Lifestyle Advice
n=185 Participants
This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
|
|---|---|---|---|
|
8-week Change in Total Cholesterol
|
-0.12 mmol/L
Interval -0.23 to -0.06
|
-0.16 mmol/L
Interval -0.31 to -0.02
|
-0.08 mmol/L
Interval -0.23 to 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksComparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N
Outcome measures
Outcome data not reported
Adverse Events
No Information on High Risk Factor Levels But Lifestyle Advice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Information on High Risk Factor Levels Nor Lifestyle Advice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information on High Risk Factor Levels and Lifestyle Advice
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place