Trial Outcomes & Findings for Computer-Aided Prevention System (NCT NCT02444715)

NCT ID: NCT02444715

Last Updated: 2016-02-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2016-02-18

Participant Flow

Participant milestones

Measure	Standard Care (SC) Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Study STARTED	46	48
Overall Study COMPLETED	36	32
Overall Study NOT COMPLETED	10	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computer-Aided Prevention System

Baseline characteristics by cohort

Measure	Standard Care (SC) n=46 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=48 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.	Total n=94 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 12.1 • n=5 Participants	60.7 years STANDARD_DEVIATION 11.3 • n=7 Participants	60.2 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.

Outcome measures

Measure	Standard Care (SC) n=32 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=28 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Systolic Blood Pressure	0.19 mmHg Standard Deviation 21.34	-9 mmHg Standard Deviation 21.37

PRIMARY outcome

Timeframe: baseline and 6 months

Population: For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.

Outcome measures

Measure	Standard Care (SC) n=41 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=37 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in HDL Level	1 mg/dl Interval -5.0 to 7.0	-2 mg/dl Interval -7.0 to 4.0

PRIMARY outcome

Timeframe: baseline and 6 months

Population: For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.

Outcome measures

Measure	Standard Care (SC) n=41 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=37 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in LDL Level	-1 mg/dl Interval -17.0 to 10.0	-6 mg/dl Interval -16.0 to 3.0

PRIMARY outcome

Timeframe: baseline and 6 months

Population: For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study.

Outcome measures

Measure	Standard Care (SC) n=30 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=32 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Triglyceride Level	-1 mg/dl Interval -33.25 to 18.0	-11 mg/dl Interval -37.5 to 10.25

PRIMARY outcome

Timeframe: baseline and 6 months

Population: For participants who did not provide final questionnaires, data was retrieved from medical records. HbA1c data is missing for 21 of the 46 SC and 21 of the 48 IC participants who started the study.

Outcome measures

Measure	Standard Care (SC) n=25 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=27 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in HbA1c Level	-0.1 percent HbA1c Interval -0.2 to 0.2	-0.1 percent HbA1c Interval -0.2 to 0.0

PRIMARY outcome

Timeframe: baseline and 6 months

Population: For participants who did not provide final questionnaires, data was retrieved from medical records. Glycaemia data is missing for 6 of the 46 SC and 13 of the 48 IC participants who started the study.

Outcome measures

Measure	Standard Care (SC) n=40 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=35 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Glycaemia Level	-0.5 mg/dl Interval -8.25 to 6.0	-2 mg/dl Interval -7.5 to 2.5

PRIMARY outcome

Timeframe: baseline and 6 months

Population: For participants who did not provide final questionnaires, data was retrieved from medical records. Weight data is missing for 9 of the 46 SC and 15 of the 48 IC participants who started the study.

Outcome measures

Measure	Standard Care (SC) n=37 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=33 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in BMI Value	0.05 kg/m^2 Standard Deviation 1.61	-0.26 kg/m^2 Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Data on fruits and vegetables consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.

Self-reported weekly portions of fruits and vegetables consumption

(During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.)

Outcome measures

Measure	Standard Care (SC) n=36 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=32 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Fruits and Vegetables Consumption	0 portions Interval -7.0 to 7.0	3.5 portions Interval -3.25 to 11.75

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Data on whole grain food consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.

Self-reported weekly portions of whole grain food consumption

(During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.)

Outcome measures

Measure	Standard Care (SC) n=36 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=32 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Whole Grain Food Consumption	0 portions Interval -4.0 to 3.0	1 portions Interval -0.25 to 7.0

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Data on sweets consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.

Self-reported weekly portions of sweets consumption

(During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.)

Outcome measures

Measure	Standard Care (SC) n=36 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=32 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Sweets Consumption	0 portions Interval 0.0 to 1.0	0 portions Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Data on physical activity was retrieved from final questionnaires. Hence, physical activity data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.

Self-reported weekly duration of physical activity of medium or high intensity

Outcome measures

Measure	Standard Care (SC) n=36 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=32 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Duration of Physical Activity medium intensity	0 minutes Interval -60.0 to 135.0	0 minutes Interval -60.0 to 112.5
Change in Duration of Physical Activity high intensity	0 minutes Interval -120.0 to 15.0	0 minutes Interval -45.0 to 30.0

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Data on quality of life was retrieved from final questionnaires. Hence, QoL data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.

The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.

In this context, the health value was specified by the participants on a subjective scale ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").

Outcome measures

Measure	Standard Care (SC) n=36 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) n=32 Participants CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Change in Quality of Life	0 units on a scale (health value) Interval -6.25 to 10.0	0 units on a scale (health value) Interval -0.25 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.

The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).

SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability.

The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.

The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.

Outcome measures

Measure	Standard Care (SC) n=26 Participants Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.	Interventional Care (IC) CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Usability: SUS Score	80.1 units on a scale (total SUS score) Standard Deviation 16.22	—

Adverse Events

Standard Care (SC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interventional Care (IC)

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

Dr. Lübomira Spassova

Luxembourg Institute of Science and Technology

Phone: +352 275 888 1

Email: lubomira.spassova@list.lu

Results disclosure agreements

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