Completado

A Tailored Medication Management Intervention for Older Adults

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Qué se está evaluando

Medication Management Remote Intervention

+ Waitlist Control

+ Medication Management In-Person Intervention

Conductual
Quiénes están siendo reclutados

A partir de 65 años
+5 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con Placebo
Intervencional
Inicio del estudio: febrero de 2021
Ver detalles del protocolo

Resumen

Patrocinador PrincipalWashington University School of Medicine
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 19 de febrero de 2021

Fecha en la que se inscribió al primer participante.

Almost 70% of older adults experience multimorbidity and medication is often the first intervention used to manage it. In fact, 90% of older adults take at least one medication and 36% take 5 or more, commonly known as polypharmacy. When taken correctly, medication can extend life-expectancy and improve quality of life. However, estimates show 40-75% of community-dwelling older adults are nonadherent, or deviate from their medication regimen. These older adults are at an increased risk of nonadherence because the physical changes associated with multimorbidity including decreased memory, fine motor skills, and visual acuity and because of the complexity polypharmacy adds to a medication routine. Nearly 43% of older adults with polypharmacy take medications that are inappropriate and can cause negative long term physical and cognitive function, which further complicates the mediation management process. Nonadherence has significant consequences which include increased health care costs, falls, institutionalization, and decreased medication effectiveness, quality of life. In fact, improving medication adherence has been identified as a public health concern by the World Health Organization. Despite this, interventions designed to improve adherence in older adults remain largely ineffective. The majority of interventions are disease or medication specific or are implemented with a "one size fits all" approach (e.g. providing standard pill organizers that may be difficult for some older adults to open). Furthermore, interventions are often implemented in a clinical setting such as doctor's office or hospital and do not consider the unique home environment where medication management typically occurs. Home environments can offer support (i.e. caregiver to set up medications) or barriers (i.e. low lighting that makes medications difficult to see) to medication management. Given the complexity of each older adult's risk factors and home environment, a more tailored, individualized approach must be considered. Tailored, individualized interventions aimed at remediating the environmental barriers in the home have been successful in improving daily activity performance for older adults. However, this type of intervention has not been tested specifically to improve medication adherence in older adults with multimorbidity and polypharmacy. We propose a tailored, individualized medication management intervention (TIMM) for community-dwelling older adults with multimorbidity and polypharmacy. TIMM is an interdisciplinary, compensatory intervention which consists of: 1) an initial in-home evaluation of medication management ability, individual risk factors, and identification of environmental barriers to independence; 2) a medication review by a pharmacist to address polypharmacy; and 3) tailored intervention by an occupational therapist to improve adherence by reducing barriers to medication management. We will conduct an equivalency randomized control trial to examine the feasibility, acceptability and preliminary efficacy of TIMM delivered remotely and in-person. The use of telehealth to deliver occupational therapy interventions for older adults has become more widely utilized, especially during the last two years. Remote interventions remove many of the barriers to in-home care including access and cost and have been shown to be an effective delivery method for OT and other medical services for older adults. Participants in the treatment group will receive the intervention delivered remotely, and participants in the waitlist control group will receive the intervention in-person, upon completion of their control period.

Título OficialA Tailored Medication Management Intervention for Older Adults
NCT04717297
Patrocinador PrincipalWashington University School of Medicine
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 33 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 65 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

3 criterios de inclusión requeridos para participar
65 and older

takes 5 or more medications

Decreased medication adherence (one or more "yes" responses on Medication Adherence Rating Scale (MARS))

2 criterios de exclusión impiden participar
Cognitive impairment as indicated by Short Blessed Test (SBT) score of 10 or more

Lives in institutional setting

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

3 grupos de intervención están designados en este estudio

33.333333333333336% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered remotely.

Grupo II

Simulado
The attention control group will receive two, 75-minute attention visits with a trained research assistant. Upon completion of waitlist period, the participants in the waitlist group will be offered the intervention in person.

Grupo III

Experimental
Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered in-person.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

Washington University

St Louis, United StatesAbrir Washington University en Google Maps
Completado1 Centros de Estudio