Clinical trial NCT03979768: Risk Assessment of Type 2 Diabetes in Pharmacies
Official title: Risk Assessment and HaemoglobinA1c (HbA1c) -Measurement in Community Pharmacies to Identify People With Undiagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 368
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eight community pharmacies offered a diabetes risk assessment including a diabetes risk assessment test only, while 11 community pharmacies
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. Our aim was to explore the capacity of Norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health.

Methods: Nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or Haemoglobin A1c (HbA1c) -group were the participants with a high risk of developing type 2 diabetes also received a HbA1c-measurement. Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. The pharmacists at the 11 HbA1c pharmacies were also trained in how to perform the HbA1c- measurement. During six months, pharmacy customers equal or over 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. In the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the HbA1c-group, participants with HbA1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.

Detailed description: Background: Due to lack of clear symptoms, type 2 diabetes can remain undetected for many years. Our aim was to explore the capacity of Norwegian community pharmacies to identify people at high risk of developing type 2 diabetes and the impact of the risk assessment service on self-rated health.

Methods: Nineteen community pharmacies were randomly allocated to a diabetes risk test only- group or Haemoglobin A1c (HbA1c) -group were the participants with a high risk of developing type 2 diabetes also received a HbA1c-measurement. Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. The pharmacists at the 11 HbA1c pharmacies were also trained in how to perform the HbA1c- measurement. During six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health. In the risk test only-group, participants with a high risk of developing type 2 diabetes were referred to their general practitioner for follow-up, while in the HbA1c-group, participants with HbA1c ≥ 48 mmol/ mol (6.5%) were referred to their general practitioner.

Eligibility criteria: Inclusion Criteria:

- age equal to or above 45 years old (increased from 18 years in the feasibility study), and being able to read and write Norwegian/English.

Exclusion Criteria:

- known diabetes, pregnancy and blood diseases that may affect measurement of Haemoglobin A1c (HbA1c).

Primary outcomes:
measure: Number of Participants with undiagnosed type 2 diabetes
timeFrame: 2 months
Secondary outcomes:
measure: Explore if there was any difference in the number of participants with a high risk of developing type 2 diabetes in the risk test only (RTO)- group and the group that also offered a HbA1c-measurement (HbA1c-group)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Bergen
name: Aslaug Johanne Risøy, PhDCandidate
role: PRINCIPAL_INVESTIGATOR
References: