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Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

Primary Purpose

Diabetes Mellitus Type 2, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intervention group
Sponsored by
VTT Technical Research Centre of Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring patient decision support, telemonitoring, self-management, remote patient monitoring, active assistance technology, selfcare

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.
  • For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
  • Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%
  • use of diabetes medication

Exclusion Criteria:

  • Patients who decline to participate
  • Patients specifically excluded by the health centre physician
  • Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring
  • Pregnancy
  • Patients with a life expectance of less than one year
  • Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months.
  • Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study

Sites / Locations

  • Sipoo Health Care Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Telemonitoring group

Arm Description

Control group received usual care

Intervention patients were given a remote patient monitoring toolbox that included a mobile telephone, software application, and assessment devices for measuring and remote reporting of hypertension and diabetes -related health parameters at home. The monitored parameters were body weight, steps, blood pressure and blood glucose. Based on their self-monitored data, patients received feedback that was automatically generated, theory-based, health promotion rich information that aimed at strengthening their self-care practices.

Outcomes

Primary Outcome Measures

Change in blood pressure
Change in Hba1c(for diabetes patients)

Secondary Outcome Measures

Achieving the desired target range
Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%.
Adverse effects
hypotension, RR < 120/80 mmHg
Hypoglycemia
p-glucose < 3.5 mmol/l
Change in body weight
Change in BMI
Change in medication
Change in FÍNSIK scores

Full Information

First Posted
March 2, 2012
Last Updated
March 9, 2016
Sponsor
VTT Technical Research Centre of Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01547156
Brief Title
Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology
Official Title
Mobile Sipoo a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VTT Technical Research Centre of Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.
Detailed Description
Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Hypertension
Keywords
patient decision support, telemonitoring, self-management, remote patient monitoring, active assistance technology, selfcare

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group received usual care
Arm Title
Telemonitoring group
Arm Type
Experimental
Arm Description
Intervention patients were given a remote patient monitoring toolbox that included a mobile telephone, software application, and assessment devices for measuring and remote reporting of hypertension and diabetes -related health parameters at home. The monitored parameters were body weight, steps, blood pressure and blood glucose. Based on their self-monitored data, patients received feedback that was automatically generated, theory-based, health promotion rich information that aimed at strengthening their self-care practices.
Intervention Type
Device
Intervention Name(s)
Intervention group
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
9 months
Title
Change in Hba1c(for diabetes patients)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Achieving the desired target range
Description
Target range for blood pressure is <= 135/85 mmHg. Target range for glycohemoglobin is <= 6.5%.
Time Frame
9 months
Title
Adverse effects
Description
hypotension, RR < 120/80 mmHg
Time Frame
9 months
Title
Hypoglycemia
Description
p-glucose < 3.5 mmol/l
Time Frame
9 months
Title
Change in body weight
Time Frame
9 months
Title
Change in BMI
Time Frame
9 months
Title
Change in medication
Time Frame
9 months
Title
Change in FÍNSIK scores
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study. For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11% use of diabetes medication Exclusion Criteria: Patients who decline to participate Patients specifically excluded by the health centre physician Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring Pregnancy Patients with a life expectance of less than one year Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months. Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study
Facility Information:
Facility Name
Sipoo Health Care Centre
City
Sipoo
Country
Finland

12. IPD Sharing Statement

Links:
URL
http://www.vtt.fi/sites/care4me/index.jsp?lang=en
Description
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Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology

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