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van CCT (UK)

Improving Patients' Education towards Management of Diabetes Mellitus

- candidate number25546
- NTR NumberNTR6209
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2016
- Secondary IDsProtocol ID EDM-1511-2016
- Public TitleImproving Patients' Education towards Management of Diabetes Mellitus
- Scientific TitleImproving Patientsí Education and Understanding to Diabetes Mellitus; a Multicenter Interventional Study.
- hypothesisPatient education plays significant role in disease management Patient education and understanding reduces the complications and adverse outcomes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus
- Inclusion criteriaa. Type 2 diabetes diagnosed by a physician at least six months prior to study enrolment determined via self-report with verification (medical records and current treatments)
b. Aged 18-75 (Malaysian national only)
c. Access to transportation for regular follow-ups
d. Patients can read with no visual impairment (flashcard arm only)
- Exclusion criteriaNot pregnant or any other medical conditions that can impede participation.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-dec-2016
- planned closingdate15-mei-2017
- Target number of participants300
- InterventionsControl Arm
Participants randomized into the control group did not receive unsolicited feedback but will continue to receive their usual medical care as per usual when visiting their doctors but are allowed to contact the research facilitator as if necessary. Participants in all three groups were required to report researcher once monthly (schedule time/date) for assessments. All the three groups screened for Hb1Ac every 3 months.

ARM 1: Flashcard Arm
Eligible participants were provided with a self-developed flashcards with disease-related information. Participants need to meet researcher on monthly basis for assessment and collection of new flashcards. All the disease-related information divided into 6 main headings; disease definition and epidemiology, risk factor and prevention, dietary care (recommended plans), treatment care, self-care practices (including self monitoring blood glucose SMBG) and critical clinical parameters (symptoms of hypo / hyperglycemic episodes). Participants received each domain flashcards on monthly basis visit. Figure 2; showed the sequence of flashcards distributed among participants. Similar pattern is applied in pharmacist counselling arm instead the information is conveyed in counselling sessions.

ARM 2: Pharmacist Intervention Arm Participants were referred through their primary physician or clinic nurses. Eligible participants were provided with a systemic booklet and homework book to record their daily activities. Also researcher has developed a monthly glucose-monitoring schedule together with counselling session (each session is about 20-40 min, depending on patients feedback response). Researcher reminds the group participants for regular counselling sessions and also provides schedule dates with time during enrolment. Both date and time confirmed with patient feasibility and convenience, however participants still reserve the right to change the either time/date or both with 24-48 hours prior notice to researcher.
- Primary outcomeAt the end of study (six-months) participants of control arm were compared with Pharmacist counselling arm and flashcard arm for:

disease related-knowledge,

understanding of care practices
- Secondary outcomeimpact of education base activity on Hb1Ac
- Timepoints0 - 3 - 6 Months
- Trial web siten/a
- statusplanned
- Sponsor/Initiator Dr. Syed Wasif Gillani
- Funding
(Source(s) of Monetary or Material Support)
Dr. Syed Wasif Gillani
- PublicationsDr. Syed Wasif Gillani Department of Clinical Pharmacy College of Pharmacy, Taibah University, Al Madinah Al Munawarrah Email: (SWG) TEL: +966538419573
- Brief summaryThis is a randomized (systemic), Multi-center parallel-group longitudinal interventional study. The study participants consist of patient diagnosed with type 2 diabetes mellitus and attending the outpatient department (OPD) for diabetic treatment. A total of 200 participants in this study will have an 80% power to detect a 0.5% difference in patient education & understanding variables in the intervention parallel groups and control arm. In order to compensate 20% loss in follow-up in each arm researcher plan to randomize a total of 300 patients (100 per arm) with type 2 diabetes mellitus to the intervention parallel groups and control arm of the study. Patients may be self-referred or referred through their primary physician. All eligible patients were screened to be included in this study. Eligible patients were also introduced to the study protocol by research coordinator to confirm participation. Patients who were interested to participate in this study, required to sign a research consent form. Patients, who were illiterate, acquire an impartial witness to explain the study protocol before participation. During the data collection process, all study forms were labelled with a unique study identifier. All collected forms were stored in a locked file cabinet in a locked office. Researcher will check for any missing or outlier values.Researcher has developed a questionnaire with multiple response questions. At the end of study (after 6 months) all the participants required to fill the questionnaire. Questionnaire consist of 24 questions (4 questions from each domain), linguistic /paraphrasing assistance provided to participants (though questionnaire previously validated). Researcher then analyse the responses and conclude participants response to represent effective arm. Data analysis was made using IBM SPSS Statistics, version 22 (Armok, NY). A probability of <0.05 was considered statistically significant for all tests. All variables were analyzed using descriptive analysis. Unadjusted comparisons between study arms were made using t-tests for continuous variables or chi-square tests for discrete variables. All data will be presented before and after adjustment for confounding and interaction.
- Main changes (audit trail)
- RECORD17-nov-2016 - 5-mrt-2017

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