Category
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Primary study
Registry of Trials»ANZCTR
Year
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2017
INTERVENTION: This randomized controlled trail (RCT) will be conducted at diabetes clinic of Capital Development Authority (CDA) hospital, located in Islamabad, Pakistan. Overall eighty (80) T2DM patients, with poorly controlled diabetes (HbA1c> 7%) will be randomized into intervention (N=40) and control groups (N=40). A baseline assessment for patients of both groups will be done for their self‐care activities and disease knowledge by using validated Urdu versions of Diabetes Self‐management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively. After the baseline evaluation, interventional group patients will be supplemented with a face to face pharmacist‐led educational intervention (60 min duration). The educational intervention and patient informatory material has been designed according to American diabetes Association (ADA) guidelines and validated after detailed conversation with the field experts. A qualified pharmacist (researcher) will educate the patients in the interventional group about disease (diabetes), its symptoms, clinical goals, self‐care activities (self‐monitoring of blood glucose, physical activity, importance of regular medication in‐take and healthy diet), and, reducing risks. Patients in the intervention group will be educated by pharmacist with the help of presentation, informatory brochures and pictograms. During 24 weeks of study, interventional group participants will be required to improve their self‐care activities and in order to keep track of self‐monitoring blood glucose they will also be provided log books to keep the record of their self‐monitored blood glucose levels during this intervention period. Intervention group patients will be educated again at their first follow visit (12th week) for their self‐care activities and any barrier (s) / problem (s) towards their self‐care will be discussed (30 min duration). Additionally a brief telephonic follow‐up by the pharmacist will be carried out for each patient four times during these 6 months intervention (at week 4,8,16 and 20). Whereas the control group patients (N=40) will receive the usual medical care. The researcher will use the interactive discussion strategy to enhance intervention group patients’ motivation to improve diabetes self‐care behaviours. Final assessments for glycaemic control (HbA1c), self‐care activities and disease knowledge, will be conducted at the end of trail (24th week) for both intervention and control groups. A brief educational programs’ satisfaction survey will be carried out at the end of the intervention (24th week) from the intervention arm participants. CONDITION: Type 2 diabetes mellitus PRIMARY OUTCOME: Change in the diabetes self‐care activities. ; The Diabetes Self‐management Questionnaire (DSMQ) will be used to measure the patient’s self‐care activities (validated Urdu version). Change in the HbA1c SECONDARY OUTCOME: Body mass index Patients knowledge about diabetes. ; Diabetes Knowledge Questionnaire (DKQ), developed for the Starr County Diabetes Education Study, has been translated and validated in Urdu language in Pakistan. ; Reference: Bukhsh A, Lee SWH, Pusparajah P, Khan AH and Khan TM (2017) Psychometric Properties of the Urdu Version of Diabetes Knowledge Questionnaire. Front. Public Health 5:139. ; INCLUSION CRITERIA: Includes poorly controlled (HbA1c>7%) T2DM, adult patients (age more than or equal to 30 years) regardless of gender; speak and understand Urdu and / or English language (s) ; having no significant co‐morbidity; not being involved in any trial / study related to diabetes during last 3 months and able to attend regular visits
Epistemonikos ID: 42577ec28cb2d188c96ca74865d373ab94fcf73a
First added on: Aug 23, 2024