None listed
Conditions
Brief summary
This study aims to examine the impact of a face to face short term (6 months) pharmacist-led educational intervention model in poorly controlled T2DM patient (HbA1c >7%) in Pakistan. In this study we will investigate the mean change in HbA1C at 6 months after the baseline, and a comparison will be made with a similar comparator group of T2DM patients who will not be provided education intervention. In addition comparison between self-care activities and disease knowledge between the groups will also be studied.
Interventions
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.
Sponsors
Study design
Eligibility
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
Exclusion criteria
Participants will be excluded if they are of other types of diabetes (gestational diabetes, T1DM); age less than 30 years; unable to answer the questionnaire independently or having hearing, vision or cognitive impairments.