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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05501223
Other study ID # P-2020-1012
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date November 2022

Study information

Verified date August 2022
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.


Description:

Patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. The intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. Follow-up is 6 months. Primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. DM2 2. 12 medications in the central prescription list Exclusion Criteria: 1. inability to give written consent (e.g., inability to understand the intervention or language barriers); 2. active cancer or palliative treatment; 3. admitted to the hospital.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Medication review
30-60 minutes extra consultation regarding the patients drugs
Standard care
Standard care i.e. visit at the Dept. of Endocrinology.

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of medications used at baseline compared to number of medications used at follow-up. Resulting in a rate of medications used at baseline compared to follow-up i.e. no. medication at follow-up/no. at baseline. The no. of medications used at baseline will be compared to the no. of medications used at follow-up. This will result in a rate i.e. no. at follow-up/no. at baseline which can be compared between groups resulting in a rate ratio. Medication usage is determined by number of medications listed in the central prescription list. 6 months
Secondary EQ5D index score. (a Euro Quality of Life 5-dimension 5-level (EQ-5D-5L) scale). The score is retrieved by using the validated EQ5D questionnaire which translates to a corresponding EQ5D index score using country specific value sets. Health related quality of life measured by EQ5D index score using Danish value sets (ranging from -0.7 (worst quality of life) to 1 (best quality of life)). 6 months
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