NCT06212713

Brief Summary

The goal of this observational study is to:

  1. 1.develop and validate a health behavior theory-based questionnaire to examine the older adults' and informal caregivers' determinants of deprescribing behavior
  2. 2.assess the psychometric properties of this new instrument
  3. 3.analyze the moderating influence of health literacy and locus of control on the effect of the determinants on deprescribing intention or behavior.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

October 9, 2023

Last Update Submit

January 8, 2024

Conditions

Keywords

Older adultInformal caregiverDeprescribingHealth behavior theories

Outcome Measures

Primary Outcomes (2)

  • Validity and reliability of the measurement tool - HBQtD

    Questionnaire administration (HBQtD) for psychometric analyse

    Throughout the entire study, approximately during 9 months

  • Correlation between deprescribing intention and behavior and deprescribing determinants using HBQtD questionnaire

    Questionnaire administration (HBQtD) and regression analysis will be performed

    Throughout the entire study, approximately during 9 months

Secondary Outcomes (2)

  • Moderating effect of health literacy using HLS19_Q12

    Throughout the entire study, approximately during 9 months

  • Moderating effect of locus of control using Multidimensional Health locus of control scale (MHLC)

    Throughout the entire study, approximately during 9 months

Study Arms (1)

Questionnaire respondents

questionnaire will be administered for validation

Other: Questionnaire administration

Interventions

Questionnaire administration - version older adults and informal caregivers

Questionnaire respondents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For the purposes of this study, older adult are people aged 60 or older. Take at least 5 regular medications: the ageing process is often accompanied by an increasing burden of chronic illness, and consequently by chronic medication use that can lead to polypharmacy, defined as taking 5 or more medications. In this study informal caregiver refers to a family member, a friend that provide care or support to a dependent older person with physical or cognitive functions declines. The relationship between the informal caregiver and the care recipient is based on solidarity. Therefore, in this study those who provided informal care are: (a) working-age adults who care for older parents with disabilities, family members, neighbors or friends; (b) people of retirement age or older who care for their partner, family members, neighbors or friends

You may qualify if:

  • Older adults
  • Age 60 years or older;
  • Taking at least 5 medications daily;
  • Having at least one chronic condition.
  • Informal caregivers
  • They self-identified as a caregiver (defined as having any role in a family member or friend's management of health and/ or medication management) of an older adult who has 60 years old or older, that are taking at least 5 medications daily;
  • The care recipient lived in the community (at home with or without the caregiver) or in a NH.

You may not qualify if:

  • Older adults
  • Suffering from psychiatric trouble;
  • Past or present drug or alcohol dependency;
  • Having a terminal illness;
  • Inability to complete a written questionnaire in French due to a functional or cognitive impairment;
  • Inability to understand and express oneself in French.
  • Informal cariegivers
  • Caregiver age under 18 years old;
  • Caregivers who are paid for the care they provide;
  • Caregiver inability to give consent and complete a written questionnaire in French;
  • Caregiver inability to understand and speak in French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Louvain-la-Neuve, 1348, Belgium

RECRUITING

Related Publications (59)

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Study Officials

  • Stephan Van den Broucke, PhD

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Van den Broucke, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

January 19, 2024

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

October 1, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations