Pharmacist-Led Study in Controlling Hypoglycemia in Older Adults With Type 2 Diabetes Mellitus (ROSE-ADAM)

April 21, 2021 updated by: University of Lincoln

Randomized Controlled Trial of Pharmacist-Led Patient Counselling in Controlling Hypoglycemic Attacks in Older Adults With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypoglycaemia is the most serious adverse effect of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in clinical trials that evaluate the impact of such type of interventions on hypoglycaemia risk, especially in older adults. Despite the increasing prevalence of chronic diseases such as diabetes in Jordan, pharmacists still provide traditional services rather than patient-centred services.

The purpose of this research is to investigate the effect of pharmacist-led, individualised, and medications-focused patient counselling on reducing episodes of hypoglycaemia compared to the usual care in older Jordanians with type 2 Diabetes Mellitus within 12 weeks.

This research is a prospective, open-label, randomised controlled trial that is conducted in the outpatient endocrinology and cardiology clinics at King Abdullah University Hospital in Jordan, with 204 elderly patients who had been diagnosed with type 2 diabetes. Participants will be randomised in a 1:1 ratio into either the intervention (SUGAR Handshake) or the usual care groups. Each participant in the SUGAR Handshake group will receive a face-to-face individualised educational session with a pharmacist at the inclusion visit, a pictogram containing the main educational information, and a reinforcement of the educational session through a phone call at week 6 of the inclusion visit. They will also receive the usual care provided by the health care professionals at the outpatient clinics. On the other hand, patients in the usual care group will only receive the routine care provided at the outpatient clinics. The duration of the trial for each participant is 12 weeks.

The qualitative study is performed through phone interviews with 8-12 participants of each group at week 6 of the inclusion visit. Participants are to be approached according to convenience sampling and the data will be analysed using content analysis.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • King Abdullah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of type 2 Diabetes Mellitus
  • Have been taking a sulfonylurea, insulin, or any three or more anti-diabetic medications

Exclusion Criteria:

  • Unable to understand instructions or to give consent.
  • Impaired mental capacity
  • On palliative care for cancer, with advanced-stage or end-stage diseases, who have psychosis or severe depression, who are terminally-ill, or with life expectancy < 6 months
  • Have been diagnosed with haemolytic anaemia or hemoglobinopathies as being self-reported or according to the patient's electronic record.
  • Unwilling to take home glucose measurements or to use the glucometer (for example because of severe hearing or visual impairment and without a caregiver to measure the blood glucose level by the glucometer)
  • Unwilling to return for follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SUGAR Handshake

Participants assigned to the intervention group will receive an individualised, pharmacist-led patient counselling session (SUGAR Handshake package) at the inclusion visit.

Participants will also receive a pictogram with the main instructions for easy recall of the counselling contents.

They will also receive a glucometer and test strips with a demonstration on proper use, to measure their fasting blood glucose levels on a daily basis for 12 weeks.

At week 6, participants will receive a phone call to reinforce the intervention and to remind them of the study protocol. For the qualitative evaluation of the intervention, a number of participants are interviewed and asked questions through the sixth week-phone call.

Additionally, participants in this group will be provided with the usual care that is normally provided in the outpatient clinics at King Abdullah University Hospital.
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.
No Intervention: Control

Participants within this group will receive the usual care provided by the health care professionals in the outpatient clinics at King Abdullah University Hospital.

They will also be provided with instructions on hypoglycemia diagnosis, and treatment and a demonstration on glucometer use at the inclusion visit. They will be asked to measure their fasting blood glucose level daily for 12 weeks.

Participants will receive a phone call at week 6 of the inclusion visit to remind them of measuring blood glucose levels and documenting hypoglycemic episodes on the diaries., plus a counselling session about hypoglycaemia recognition and treatment at the inclusion visit.

For the qualitative evaluation of the study, a number of participants will be interviewed and asked questions through the sixth week-phone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of total episodes of hypoglycaemia
Time Frame: 12 weeks
The frequency of hypoglycemia will be calculated as the number of total hypoglycemic episodes/person/ 12 weeks. Total hypoglycemia is defined as the summation of severe, symptomatic, and asymptomatic episodes of hypoglycaemia.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of severe hypoglycaemia
Time Frame: 12 weeks

The frequency of severe hypoglycemia will be calculated as the number of severe hypoglycemic episodes/person/ 12 weeks. Severe hypoglycemia is defined as any event requiring the assistance of another person to administer carbohydrate and glucagon or take any other corrective actions, accompanied by neurological recovery after the corrective actions.

Participants will be provided with diaries to document severe episodes of hypoglycemia
12 weeks
Frequency of asymptomatic hypoglycemia
Time Frame: 12 weeks

The frequency of asymptomatic hypoglycemia will be calculated as the number of asymptomatic hypoglycaemia episodes/person/ 12 weeks. asymptomatic hypoglycaemia is defined as an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L).

Participants will be provided with diaries to document fasting blood glucose levels by which asymptomatic episodes will be diagnosed.
12 weeks
Frequency of symptomatic hypoglycemia
Time Frame: 12 weeks

The frequency of symptomatic hypoglycemia will be calculated as the number of symptomatic hypoglycemic episodes/person/ 12 weeks. Symptomatic hypoglycemia is defined as an event during which the patient experiences typical symptoms of hypoglycaemia (sweating, dizziness, light-headedness, tremor, hunger, headache) whether they are accompanied by a measured plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L) or not.

Participants will be provided with diaries to document symptomatic episodes of hypoglycemia.
12 weeks
Proportion of patients experiencing hypoglycaemia
Time Frame: 12 weeks
proportion of patients who experience at least one hypoglycaemic attack of each type
12 weeks
Time to the first hypoglycaemic attack
Time Frame: 12 weeks
the number of the day when a participant will experience the first hypoglycaemic attack of any type after randomisation.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lincoln

Investigators

  • Study Director: Keivan Ahmadi, PhD, Associate Professor in Pharmacology & Therapeutics, Lincoln Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-May-0170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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