Trial Outcomes & Findings for E-health Care Process Support for Diabetes Type II Patients (NCT NCT01566981)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

1 year

Results posted on

2014-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Diabetes With ICT Support (E-diabetes) The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up, consequently 53 patients were included in final analysis	Diabetes Without Support 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow up, so 54 patients were included in final analysis.
Overall Study STARTED	58	62
Overall Study COMPLETED	53	54
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Diabetes With ICT Support (E-diabetes) The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up, consequently 53 patients were included in final analysis	Diabetes Without Support 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow up, so 54 patients were included in final analysis.
Overall Study Lost to Follow-up	5	8

Baseline Characteristics

E-health Care Process Support for Diabetes Type II Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetes With ICT Support (E-diabetes) n=58 Participants The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.	Diabetes Without Support n=62 Participants The group of randomly selected patients with DM type II, without software application and web-based support.	Total n=120 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 10.5 • n=5 Participants	54.7 years STANDARD_DEVIATION 11.1 • n=7 Participants	55.5 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Years of DM treatment	5.1 years STANDARD_DEVIATION 5.7 • n=5 Participants	5.7 years STANDARD_DEVIATION 4.8 • n=7 Participants	5.5 years STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Diabetes With ICT Support (E-diabetes) n=53 Participants The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up, consequently 53 patients were included in final analysis	Diabetes Without Support n=54 Participants 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow and 54 patients were included in final analysis.
Change From Baseline in HbA1C at 1 Year.	0.6925 percentage of glycated haemoglobin Standard Deviation 1.4708	0.1707 percentage of glycated haemoglobin Standard Deviation 1.0617

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	Diabetes With ICT Support (E-diabetes) n=54 Participants The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up, consequently 53 patients were included in final analysis	Diabetes Without Support n=53 Participants 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow and 54 patients were included in final analysis.
Body Mass Index at 1 Year	31.76 Kg/m2 Standard Deviation 4.87	32.6 Kg/m2 Standard Deviation 5.14

SECONDARY outcome

Timeframe: one year

WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 ('no limitation at all') to 5 ('severely limited'); for 'change in health' score 1 means 'much better' and score 5'much worse'. Sub-scales are averaged to compute a total score.

Outcome measures

Outcome measures
Measure	Diabetes With ICT Support (E-diabetes) n=53 Participants The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process. 5 patients were lost to follow up, consequently 53 patients were included in final analysis	Diabetes Without Support n=54 Participants 62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support. 8 patients were lost to follow and 54 patients were included in final analysis.
Patients' Functional Health Status Via WONCA-COOP Questionnaire.	2.12 units on a scale Standard Deviation 0.66	1.89 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: baseline and one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and six months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and six months

Outcome measures

Outcome data not reported

Adverse Events

Diabetes With ICT Support (E-diabetes)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetes Without Support

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. Rade Iljaž

Department of family medicine, Medical Faculty in Ljubljana

Phone: '386 31 300- 381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place