NCT05501223

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 3, 2021

Last Update Submit

August 12, 2022

Conditions

Polypharmacy

Keywords

Polypharmacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Intervention

OTHER

Standard care + medication review

Other: Medication reviewOther: Standard care

Control

OTHER

Standard care

Other: Standard care

Interventions

Medication reviewOTHER

30-60 minutes extra consultation regarding the patients drugs

Intervention
Standard careOTHER

Standard care i.e. visit at the Dept. of Endocrinology.

ControlIntervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • DM2
  • medications in the central prescription list

You may not qualify if:

  • inability to give written consent (e.g., inability to understand the intervention or language barriers);
  • active cancer or palliative treatment;
  • admitted to the hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

MeSH Terms

Interventions

Medication ReviewStandard of Care

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care ManagementQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., PhD student

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 15, 2022

Study Start

November 1, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

DK(1)