This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice
Novo Nordisk Investigational Site
Paris La Défense Cedex, France
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.
Time frame: Week 6
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.
Time frame: Week 6
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).
Time frame: Week 6
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.
Time frame: Week 6
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.
Time frame: Week 6
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.
Time frame: Week 0
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.
Time frame: Week 6
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.
Time frame: Week 6
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
Time frame: Weeks 0 - 6
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