History of Changes for Study: NCT05629936

Improving Medication Therapy Through a Digital Interdisciplinary Model (MTO)

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Version	A	B	Submitted Date	Changes
1			November 17, 2022	None (earliest Version on record)

Study Identification


Unique Protocol ID:	UMU-MTO-2022
Brief Title:	Improving Medication Therapy Through a Digital Interdisciplinary Model (MTO)
Official Title:	Improving Medication Therapy and Patient Involvement Through a Digital Interdisciplinary Model Among Old People in Primary Care Living in Sparsely Populated Regions in Sweden
Secondary IDs:

Study Status


Record Verification:	November 2022
Overall Status:	Not yet recruiting
Study Start:	November 2022
Primary Completion:	December 2025 [Anticipated]
Study Completion:	December 2026 [Anticipated]

First Submitted:	November 7, 2022
First Submitted that Met QC Criteria:	November 17, 2022
First Posted:	November 29, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	November 17, 2022
Last Update Posted:	November 29, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Umeå University
Responsible Party:	Principal Investigator Investigator: Maria Gustafsson Official Title: Principal investigator Affiliation: Umeå University
Collaborators:	Region Västerbotten

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

This study investigates if a digital interdisciplinary medicine therapy optimization (MTO) model in primary care can improve medication therapy, quality of life and adherence among patients >65 years living in sparsley populated areas. The intervention includes digital medication interviews, comprehensive medication reviews, team based patient discussions and follow-ups.

Detailed Description:

A pilot study to develop the MTO-model including 10-15 patients, will be carried out and appropriate adjustments to the model will be made before starting the main study. Patients meeting the inclusion criteria will be invited to participate in the study and sent three questionnaires, MARS-5, EQ-5D-5L and BMQ-general, to fill in before starting the intervention. Baseline in this digital intervention is a medication interview with a clinical pharmacist. Based on the information from this interview, journal- and laboratory data, a comprehensive medication review will be conducted and a preliminary proposal discussed in a digital interdisciplinary meeting resulting in a final MTO-plan. The patients will be informed by their physician if any medication changes have been made and follow-up meetings with a pharmacist will take place 1-2,4 and 12 weeks after baseline and in addition of requested by the patients or if the pharmacist consider it necessary. In addition to the prescheduled meetings with the patient, the intervention includes repeated medical journal reviews every second week during the 12-weeks intervention. After the last follow-up at 12 weeks, the patient will be asked to fill in the three questionnaires; MARS-5, EQ-5D-5L and BMQ-general.

Conditions


Conditions:	Drug Use
Keywords:	Telemedicine Medication reconciliation Clinical pharmacist Elderly Adherence Drug-related problems

Study Design


Study Type:	Interventional
Primary Purpose:	Health Services Research
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	100 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
digital intervention Digital intervention	digital interdisciplinary intervention Digital medication interview, comprehensive medication review, interdisciplinary patient team discussion followed by a MTO-plan, follow-ups

Outcome Measures


Primary Outcome Measures:
1.	Change in self-reported health state: EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) [ Time Frame: Change in self-reported health state between baseline and 12 weeks ] Assessing health-related quality of life through the EQ-5D-5L-questionnaire. EQ VAS score ranging between 0 and 100, with higher score indicating a higher overall self-rated health status.
2.	Change in self-reported adherence: Medication Adherence Report Scale-5 (MARS-5) [ Time Frame: Change in self-reported adherence between baseline and 12 weeks ] Assessing medication adherence through MARS-5 questionnaire. Total score ranging between 5 and 25, with higher scores indicating a higher level of adherence.
3.	Change in self-reported beliefs about medicines in general: The Beliefs about Medicines Questionnaire - general (BMQ-general) [ Time Frame: Change in self-reported beliefs about medicines between baseline and 12 weeks ] Assessing beliefs about medicines in general through BMQ-general questionnaire. BMQ-general consists of three different subscales (overuse, harm and benefit) with a total score ranging between 4-20 for each subscale. In two of the subscales (overuse and harm) higher scores indicates a more negative orientation towards medicines in general and in the subscale benefit a higher score indicates a more positive orientation towards medicines.

Eligibility


Minimum Age:	65 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: 5 or more medications or recommended by their physician Living at home (i.e not in nursing home) Registered at one of seven specified primary care centers Exclusion Criteria: Do not speak Swedish or unable to communicate Home care services Confirmed major NCD Scheduled for palliative care

Contacts/Locations


Locations:

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: