Advance Health Mobile APP for the Self Management of Diabetes type2
ConditionDiabetes Mellitus Type 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversiti Putra Malaysia
About this trial
Digital health using mobile health (mHealth) tools, such as telehealth and text messaging, and or mobile Apps can improve blood glucose levels in patients with type 2 diabetes. This intervention is designed to improve self-management of diabetes and blood glucose levels in diabetic patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The presence of T2D and at least 1 recorded HbA1c level of 8.0% or higher in the past 6 months
Age between ages 21 and 85 years,
Receiving primary care at the clinical site
Having fluency in English/ Urdu in reading and writing
Disqualifiers
Planning to move away from the study site
Being pregnant or in lactation, (6) being unable to send or read text messages on a mobile phone,
Having a history of receiving or planning surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Diabetes self management @ click
BehavioralA mobile application tailored for patients with Type 2 diabetes, aiming to enhance their self-management practices will be used for the intervention arm. The app includes features such as medication tracking, appointment scheduling, patient data storage, advice for treatment and follow-ups, health education and promotion, and real-time health monitoring.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Diabetes Self-Management
DSMQ-R will assess Diabetes self-management. The DSMQ-R is a multidimensional questionnaire with 27 items regarding essential self-management practices for T1D and T2D (including diabetes-adjusted eating, glucose testing/monitoring, medication taking, physical activity, and cooperation with the diabetes team). 4 Subscales: * 'Glucose Management' (GM), 11 items: 1, 4, 6, 10, 12, 21, 22, 23, 24, 26, 27 (10 and 12 must be inverted). * 'Dietary Control' (DC), 7 items: 2, 5, 9, 13, 17, 18, 25 (5, 13 and 18 must be inverted). * 'Physical Activity' (PA), 3 items: 8, 11, 15 (11 and 15 must be inverted). * 'Health-Care Use' (HU), 4 items: 3, 7, 14, 19 (7 and 14 must be inverted). SCALE SCORE = ACTUAL SUM OF ITEMS / MAXIMUM POSSIBLE SUM OF ITEMS x 10
Time frame
6- months from baselineSecondary outcomes
1
Hemoglobin A1C
Hemoglobin A1C will be measured by taking blood samples.
Time frame
6- months from baseline2
Adherence to medication
SEAMS URDU VERSION WILL BE USED FOR SEAMS Urdu version. It is of 13 questions with a score ranging from 13-39. Higher scores show better adherence
Time frame
6- months from baseline3
Health related quality of life
Health-related quality of life will be assessed by EQ 5D3L. The EQ-5D-3L Index score summarizes each possible health state on a numerical scale ranging from -0.594 to 1, where a score of 1 indicates full health and scores of 0 and less than 0 indicate a state equivalent to being dead, and a state
Time frame
6- months from baselineSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: