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Risk Assessment of Type 2 Diabetes in Pharmacies

Not Applicable
Completed
Conditions
Type2 Diabetes
Interventions
Other: Diabetes risk assessment service in Norwegian community pharmacies
Registration Number
NCT03979768
Lead Sponsor
University of Bergen
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
368
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HbA1c-group /pharmaciesDiabetes risk assessment service in Norwegian community pharmaciesOffered a diabetes risk assessment service including a measurement of Haemoglobin A1c (HbA1c) to the people with a high risk of developing type 2 diabetes on the risk assessment form (The Finnish Diabetes Risc Score (FINDRISC) to those with a western background, and Leicester Risk Assessment (LRA) form for those with a non-western background.
Risk Assessment Only pharmacies (RTO-group)Diabetes risk assessment service in Norwegian community pharmaciesOffered a diabetes risk assessment service without any blood sample testing.
Primary Outcome Measures
NameTimeMethod
Number of Participants with undiagnosed type 2 diabetes2 months

Number of Participants with undiagnosed type 2 diabetes

Secondary Outcome Measures
NameTimeMethod
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)Baseline

Find the number of participants with a high risk of developing type 2 diabetes

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