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Pharmacist-Led Study in Controlling Hypoglycemia in Older Adults With Type 2 Diabetes Mellitus

NCT04081766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2021-04-22

No results posted yet for this study

Summary

This study involves two parts: a randomised controlled trial, and a nested qualitative study.

The main aim of the trial is to evaluate the effectiveness of a pharmacist-led, medications-focused patient counselling on reducing the frequency of hypoglycaemia in older adults diagnosed with type 2 Diabetes Mellitus within 12 weeks in Jordan.

The study hypothesis is that individualised patient counselling which is provided by pharmacists and involves recommendations about anti-diabetic medications will reduce the risk of hypoglycaemia by preventing further episodes in the elderly Jordanians with type 2 Diabetes Mellitus.

The qualitative study aims at evaluating the experience of participants in both groups with the study (process evaluation). This involves exploring which components are effective and which are not with the reasons, the contextual factors affecting the delivery and implementation of the study and the intervention, and how the study and the intervention can be scaled up in the future.

Conditions

  • Diabetes Mellitus Type 2 With Hypoglycemia

Interventions

BEHAVIORAL

SUGAR Handshake

An interactive patient counselling session delivered by a pharmacist which mainly focuses on medication-related instructions towards preventing hypoglycaemia in addition to recommendations about hypoglycemia early recognition, causes, and treatment. The SUGAR Handshake is individualised according to shared decision making and each participant's characteristics. Components of the SUGAR Handshake intervention will be covered under five main domains: 1. Signs and symptoms of hypoglycemia. 2. Understanding the underlying causes of hypoglycaemia such as misuse of anti-diabetic medications. 3. Good glycaemic control and self-monitoring, which mainly includes instructions on handling the anti-diabetic medications. 4. Acknowledgement by the patient 5. Recap and summary The pictogram contains the main recommendations for easy recall by the participant. Moreover, the intervention will be reinforced by a phone call at week 6 of the inclusion visit.

Sponsors & Collaborators

  • University of Lincoln

    lead OTHER

Principal Investigators

  • Keivan Ahmadi, PhD · Associate Professor in Pharmacology & Therapeutics, Lincoln Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-09
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081766 on ClinicalTrials.gov