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Protocol for a Multi-site Pilot Study of the OptiMed Clinical Trial

NCT06688591 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-14

No results posted yet for this study

Summary

Background: Optimal medication management is one of the essential preconditions for polymedicated home-dwelling older adults with multiple chronic conditions to remain at home and preserve their quality of life and autonomy. This study aims to explore the feasibility and acceptability of an evidence-based, multi-component, interprofessional intervention programme supported by informal caregivers to decrease medication related problems (MRPs) among polymedicated, home-dwelling older adults with multiple chronic conditions.

Methods: The pragmatic multi-site OptiMed pilot study will use an open-label design, where participants know what they are signing up for and will take place in primary healthcare settings in Portugal and Switzerland. The research population will comprise polymedicated home-dwelling adults aged 65 years old or more, at risk of MRPs and receiving community-based healthcare.

Discussion: This pilot study will focus on the recruitment and collaboration of study participants and piloting the feasibility of the evidence-based, multi-component, interprofessional intervention programme. The full-scale study, following on from the OptiMed pilot study, will support the development of a standardised, evidence-based, multi-component, interprofessional intervention programme to reduce MRPs. It will also be an essential part of follow-up research programmes on the multiple roles of informal caregivers, as it will put their coordination tasks into perspective with their own needs.

Conditions

  • Polypharmacy
  • Multiple Chronic Conditions

Interventions

OTHER

Intervention programme to optimise medication management and prevent MRPs

The intervention is based on a four-step patient empowerment process: 1) the patient understands their role; 2) the patient acquires sufficient knowledge to be able to engage with their healthcare professionals; 3) the patient improves their skills; and 4) there is a facilitating environment (30). Each older adult participant's plan will be unique and consider their preferences, medication literacy and treatment adherence.

Sponsors & Collaborators

  • Polytechnic of Leiria

    collaborator UNKNOWN

  • Institute for Primary Health Care BIHAM, University of Bern

    collaborator UNKNOWN

  • HES-SO Valais-Wallis

    lead OTHER

Principal Investigators

  • Henk Verloo, PhD · HES-SO Valais-Wallis

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2022-12-06
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688591 on ClinicalTrials.gov