Clinical trial NCT04081766: Pharmacist-Led Study in Controlling Hypoglycemia in Older Adults With Type 2 Diabetes Mellitus
Official title: Randomized Controlled Trial of Pharmacist-Led Patient Counselling in Controlling Hypoglycemic Attacks in Older Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2 With Hypoglycemia
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus
Hypoglycemia
Counseling
Older Adults
Lead sponsor: University of Lincoln
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 212
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of total episodes of hypoglycaemia
timeFrame: 12 weeks
Secondary outcomes:
measure: Frequency of severe hypoglycaemia
timeFrame: 12 weeks
measure: Frequency of asymptomatic hypoglycemia
timeFrame: 12 weeks
measure: Frequency of symptomatic hypoglycemia
timeFrame: 12 weeks
measure: Proportion of patients experiencing hypoglycaemia
timeFrame: 12 weeks
measure: Time to the first hypoglycaemic attack
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
Study officials:
affiliation: Associate Professor in Pharmacology & Therapeutics, Lincoln Medical School
name: Keivan Ahmadi, PhD
role: STUDY_DIRECTOR
References:
citation: Almomani HY, Pascual CR, Al-Azzam SI, Ahmadi K. Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention. Res Social Adm Pharm. 2021 May;17(5):885-893. doi: 10.1016/j.sapharm.2020.07.012. Epub 2020 Jul 29.