Risk Assessment of Type 2 Diabetes in Pharmacies

NCT03979768 | Completed

• 1 other identifier: 2016/808
• Study Type: interventional
• Target: 368
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants with undiagnosed type 2 diabetes

  Number of Participants with undiagnosed type 2 diabetes

  2 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Risk Assessment Only pharmacies (RTO-group)

EXPERIMENTAL

Offered a diabetes risk assessment service without any blood sample testing.

Other: Diabetes risk assessment service in Norwegian community pharmacies

HbA1c-group /pharmacies

EXPERIMENTAL

Offered 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.

Other: Diabetes risk assessment service in Norwegian community pharmacies

Interventions

Diabetes risk assessment service in Norwegian community pharmacies OTHER

Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. 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.

HbA1c-group /pharmacies; Risk Assessment Only pharmacies (RTO-group)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Bergen: lead

Study Officials

• Aslaug Johanne Risøy, PhDCandidate

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eight community pharmacies offered a diabetes risk assessment including a diabetes risk assessment test only, while 11 community pharmacies

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: June 7, 2019
• Study Start: September 15, 2016
• Primary Completion: June 30, 2017
• Study Completion: May 30, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share