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Mobile Phone Applications and Quality of Life

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dbees; diabetes mobile phone application
control group
Sponsored by
Medical Research Foundation, The Netherlands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring mobile phone application, diabetes type 1, self-management, telemedicin

Eligibility Criteria

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

Inclusion Criteria:

  • diabetes type 1
  • >18 years old
  • patient having a smartphone, who are familiar with its use

Exclusion Criteria:

  • previous or actual use of a diabetes application
  • pregnant

Sites / Locations

  • Isala Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

use of the diabetes application

Control arm without app (usual care)

Arm Description

Outcomes

Primary Outcome Measures

Quality of Life

Secondary Outcome Measures

HbA1c
usability of the application
questionnaire System Usability Scale (SUS)
Self-monitoring of blood glucose (SMBG)
frequency of blood glucose monitoring

Full Information

First Posted
September 26, 2011
Last Updated
October 23, 2012
Sponsor
Medical Research Foundation, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT01444534
Brief Title
Mobile Phone Applications and Quality of Life
Official Title
Influence of a Mobile Phone Application on Quality of Life of Patients With Type 1 Diabetes Mellitus: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Foundation, The Netherlands

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The use of smartphones has increased substantially in recent years. Apart from making phone calls and sending short messages, these smartphones can also function as a computer on which one can download computer programs (the so-called applications). Health applications are increasingly developed and may be a new tool for education of patients and communication between healthcare providers and their patients, possibly contributing to a better care for patients with chronic diseases such as diabetes. Since the number of patients with diabetes mellitus and the number of people having a smartphone are rising, it is investigated whether applications on smartphones may be used to support lifestyle changes and self-monitoring of bloodglucose control, possibly leading to an improved glycaemic regulation in the group of patients with diabetes mellitus. Large randomized controlled trials have shown that a stable glycaemic regulation is important to reduce morbidity and mortality and to improve quality of life (QOL). Self-monitoring of blood glucose is an important tool to realize an optimal glycaemic regulation in patients with type 1 diabetes mellitus (T1DM). Apart from a good glycaemic control, QOL is essential in diabetic patients. A reduced QOL is associated with progression of the disease, worse intake of medication and an increased mortality in patients with T1DM and diabetes mellitus type 2. The increasing costs associated with the rising number of diabetic patients makes that research investigating cheaper alternatives in the care for patients with diabetes are needed. The switch from a written logbook to an electronic logbook may simplify the care for diabetes patients. By means of an application all variables (food intake, physical exercise, glucose day curves, insulin units, reminders to take medication) are integrated in one program. But whether this digitalisation also improves QOL of the patient is still unclear. Therefore the aim of this study is to evaluate the effect of a diabetes application on the (QOL) for type 1 diabetic patients.
Detailed Description
Participants in both groups were invited to participate after their periodical visit to the doctor or the hospital-based nurse specialised in the care for diabetes patients. All participants in this study were adults with T1DM having a smartphone. All participants will complete the The Short Form Health Survey (SF-36) and the Problem Areas In Diabetes questionnaire (PAID) at baseline and after three months of follow-up. Baseline information, including socio demographic information (age, sex, highest level of school education), and clinical characteristics (diabetes duration, insulin therapy and presence and severity of diabetes complications) will be collected in a database. Moreover parameters such as blood pressure, body weight, HbA1c and lipid profile will be added. Sample size calculation The study was powered to detect a between-group mean difference of 10 points in the The Short Form Health Survey (SF-36) questionnaire after 3 months. With a power of 80%, alpha 0.05, the total sample size of the study should be 62 patients (31 in each group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
mobile phone application, diabetes type 1, self-management, telemedicin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
use of the diabetes application
Arm Type
Experimental
Arm Title
Control arm without app (usual care)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Dbees; diabetes mobile phone application
Intervention Description
Participants randomized to the intervention group (G2) were asked to stop using their paper logbook and start using an electronic logbook on their computer and mobile phone using an application of Dbees. The Dbees software enables the mobile phone to be used as a small computer to record the blood glucose values, dose of insulin injection, daily carbohydrate intake, amount of physical activity, and blood pressure.
Intervention Type
Device
Intervention Name(s)
control group
Intervention Description
Participants in the control group (G1) continued using their paper logbook (usual care) and had no electronic logbook. Patients in the control group were requested not to use another mobile phone application instead of or besides their paper logbook.
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
3 months
Title
usability of the application
Description
questionnaire System Usability Scale (SUS)
Time Frame
3 months
Title
Self-monitoring of blood glucose (SMBG)
Description
frequency of blood glucose monitoring
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diabetes type 1 >18 years old patient having a smartphone, who are familiar with its use Exclusion Criteria: previous or actual use of a diabetes application pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk J. Bilo, MD/PhD
Organizational Affiliation
Isala clinics, medical research foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Clinics
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

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