Improving Medication Therapy Through a Digital Interdisciplinary Model (MTO)
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ClinicalTrials.gov Identifier: NCT05629936 |
Recruitment Status :
Not yet recruiting
First Posted : November 29, 2022
Last Update Posted : November 29, 2022
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Sponsor:
Umeå University
Collaborator:
Region Västerbotten
Information provided by (Responsible Party):
Maria Gustafsson, Umeå University
Tracking Information | |||||
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First Submitted Date ICMJE | November 7, 2022 | ||||
First Posted Date ICMJE | November 29, 2022 | ||||
Last Update Posted Date | November 29, 2022 | ||||
Estimated Study Start Date ICMJE | November 2022 | ||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Improving Medication Therapy Through a Digital Interdisciplinary Model | ||||
Official Title ICMJE | Improving Medication Therapy and Patient Involvement Through a Digital Interdisciplinary Model Among Old People in Primary Care Living in Sparsely Populated Regions in Sweden | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Drug Use | ||||
Intervention ICMJE | Other: digital interdisciplinary intervention
Digital medication interview, comprehensive medication review, interdisciplinary patient team discussion followed by a MTO-plan, follow-ups
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Study Arms ICMJE | digital intervention
Digital intervention
Intervention: Other: digital interdisciplinary intervention
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2026 | ||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 65 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | |||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05629936 | ||||
Other Study ID Numbers ICMJE | UMU-MTO-2022 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Maria Gustafsson, Umeå University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Umeå University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Region Västerbotten | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Umeå University | ||||
Verification Date | November 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |