Mobile Phone Applications and Quality of Life

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanne Kleefstra, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01444534
First received: September 26, 2011
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: Dbees; diabetes mobile phone application
Device: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Influence of a Mobile Phone Application on Quality of Life of Patients With Type 1 Diabetes Mellitus: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • usability of the application [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    questionnaire System Usability Scale (SUS)

  • Self-monitoring of blood glucose (SMBG) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    frequency of blood glucose monitoring


Enrollment: 65
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: use of the diabetes application Device: Dbees; diabetes mobile phone application
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.
Active Comparator: Control arm without app (usual care) Device: control group
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444534

Locations
Netherlands
Isala Clinics
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Principal Investigator: Henk J. Bilo, MD/PhD Isala clinics, medical research foundation
  More Information

No publications provided

Responsible Party: Nanne Kleefstra, ass. professor, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01444534     History of Changes
Other Study ID Numbers: Pameijer-2011
Study First Received: September 26, 2011
Last Updated: October 23, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
mobile phone application
diabetes type 1
self-management
telemedicin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014