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PsychologicalHBQtDNCT06212713

Developement and Validation of the Health Behavior Questionnaire Towards Deprescribing (HBQtD)

An observational study of Psychological, run by Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this observational study is to: 1. develop and validate a health behavior theory-based questionnaire to examine the older adults' and informal caregivers' determinants of deprescribing behavior 2. assess the psychometric properties of this new instrument 3. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological
What is being tested?
Questionnaire administration
How many people
600 participants
Where
1 siteBelgium
Study dates
1 Oct 2023to Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Stephan Van den Broucke, PhD contact

003210479046

stephan.vandenbroucke@uclouvain.be

Belgium1 site, 1 recruiting

  • UCLouvain

    Louvain-la-Neuve, 1348

    Stephan Van den Broucke, PhD

    Recruiting

Other trials in Belgium

About this study

Official title: Development and Validation of a Health Behaviour Theory-based Questionnaire to Explore the Willingness of Older Adults and Informal Caregivers to Deprescribe

The goal of this observational study is to:

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

Participants will be involved in the validating process by completing the questionnaire to be validated, as well as the HLS19_Q12 for health literacy and the MHLC questionnaire for locus of control.

Read the detailed description

BIBLIOGRAPHIC REFERENCES Prescribing medication is an essential dimension in the care of the older adults (i.e. people aged 60 or 65 and over). However, the ageing process leads to physiological changes that can increase the risk of adverse drug events, and inappropriate polypharmacy can contribute to drug-drug interactions, lower medication adherence, significant costs to both the patient and the healthcare system, and also reduce people's ability to perform activities of daily living.

Therefore, it is important thinking about deprescription, defined by Reeve et al. (2022) as "a planned/ supervised process of dose reduction or the stopping of medicines that may be causing harm or conferring no additional benefit".

As implementation deprescribing requires a complexes changes to established patters of behaviors, understanding the cognitive mechanisms underlying patient's and caregiver's behavior with respect to deprescribing, seems essential to improve the collaborative work between the patient, or even the caregivers, and the health professionals, to achieve the best health outcomes for the patient.

In reality, health behavior theories provides a series of concepts deriving from social, cognitive and motivational psychology, that can be useful in understanding why people behave in certain ways in relation to their health.

Screening Tools The patients' attitudes towards deprescribing (PATD) questionnaire, and its revised version questionnaire (rPATD), and Beliefs about Medicines Questionnaire (specific section) (BMQ-Specific) are 2 instruments widely used. However, this questionnaires don't consider critical domains that can be relevant to deprescribing, such as self-efficacy beliefs, outcome expectations, subjective norms, health goals, environmental barriers and enablers, among others.

Hypothesis The investigators hypothesise that some of the gaps in existing tools will be filled by using health behaviour concepts in the development of an assessment tool.

STUDY DESIGN AND METHODOLOGY APPLIED Type of study: Questionnaire development and validation - older adult and informal caregiver version

Study configuration The initial questionnaire was developed considering the results of a previous systematic review (article currently being written), which was intended to identify (concepts included in) behavioral health theories (HBTs) that explain older adults' and informal caregivers' deprescribing intention and/or their actual deprescribing behavior, as well as the rPATD questionnaire and BMQ questionnaire.

The initial version for informal caregivers was developed by modifying the wording of the items, in the version for the older adults, adapting them for informal caregivers.

Another two questionnaires will be used in this study: one that measure health literacy (HLS19_Q12) and another one that assess the locus of control (Multidimensional Health Locus of control scale, MHLC).

The development and validation of the questionnaire comprise 4 main steps:

  1. Item Development
  2. Preliminary pilot testing
  3. Colleagues questionnaire feedback
  4. "Cognitive pre-test" performed with older adults and informal caregivers to check the linguistic and analytical construction of the items,
  5. First round with healthcare professionals and second round with older adults and informal carers for a self-administered questionnaire and focus group.
  6. Pre-test of the questionnaire - older adult and informal caregiver version
  7. Validation of the questionnaire - older adult and informal carer versions, using exploratory factor analysis

Strategies for recruiting participants To recruit participants, several organisations and institutions will be contacted.

Data Management Responsibilities The two questionnaire versions will be either a paper version for self-administration and an electronic version available online.

DISSEMINATION OF RESULTS AND PUBLICATION POLICY The progress and results of this study will be discussed with the Di-Prescribe research team. At the end of the study, a scientific publication will be written by the co-investigator (Sara Alves Jorge) under the supervision of the sponsor representative and Prof Van den Broucke. A paper will also be written for publication in a peer-journal. Acknowledgements will be made to all those who will make this work possible, including healthcare professionals, the different institutions and organizations that will be contacted, as well as the older adults and informal caregivers who will take part in the study. In addition, some people who will be indirectly involved, in particular by giving support and guidance, will also be recognized.

Conditions
Psychological
Being tested
Questionnaire administration
Keywords
Older adult, Informal caregiver, Deprescribing, Health behavior theories

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire administrationOther

    Questionnaire administration - version older adults and informal caregivers

Study groups in NCT06212713
Study groupRoleWhat they receive
Questionnaire respondentsquestionnaire will be administered for validation
Receives: Other: Questionnaire administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity and reliability of the measurement tool - HBQtD

    Questionnaire administration (HBQtD) for psychometric analyse

    Measured: Throughout the entire study, approximately during 9 months

  2. Correlation between deprescribing intention and behavior and deprescribing determinants using HBQtD questionnaire

    Questionnaire administration (HBQtD) and regression analysis will be performed

    Measured: Throughout the entire study, approximately during 9 months

Secondary outcomes (2)

  1. Moderating effect of health literacy using HLS19_Q12

    HLS19_Q12 questionnaire administration and regression analysis will be performed

    Measured: Throughout the entire study, approximately during 9 months

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

    MHLC scale administration and regression analysis will be performed

    Measured: Throughout the entire study, approximately during 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start1 Oct 2023
  3. Primary completionMay 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212713
Sponsor's protocol ID
DEPRESCRIBE
Acronym
HBQtD
Status last verified
Jan 2024
First submitted
9 Oct 2023
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abouzaid, S., Willemse, E., Remmen, R., Schmitz, O., Macq, J., Declercq, A., Arnaut, C., Forest, M., Denis, A., Vinck, I., Defourny, N., & Farfan-Portet, M. (s. d.). SUPPORT FOR INFORMAL CAREGIVERS - AN EXPLORATORY ANALYSIS.

  • Aithal, A., & Aithal, P. S. (2020). Development and Validation of Survey Questionnaire & Experimental Data - A Systematical Review-based Statistical Approach (SSRN Scholarly Paper No 3724105). https://doi.org/10.2139/ssrn.3724105

  • Ajzen, I. (1991). The Theory of Planned Behavior.

  • Ajzen, I., & Madden, T. J. (1986). Prediction of goal-directed behavior : Attitudes, intentions, and perceived behavioral control. Journal of Experimental Social Psychology, 22(5), 453-474. https://doi.org/10.1016/0022-1031(86)90045-4

  • Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.

    PubMed 15090118

  • Baumgartner AD, Clark CM, LaValley SA, Monte SV, Wahler RG Jr, Singh R. Interventions to deprescribe potentially inappropriate medications in the elderly: Lost in translation? J Clin Pharm Ther. 2020 Jun;45(3):453-461. doi: 10.1111/jcpt.13103. Epub 2019 Dec 24.

    PubMed 31873955

  • Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly. An update. Arch Intern Med. 1997 Jul 28;157(14):1531-6.

    PubMed 9236554

  • Chock YL, Wee YL, Gan SL, Teoh KW, Ng KY, Lee SWH. How Willing Are Patients or Their Caregivers to Deprescribe: a Systematic Review and Meta-analysis. J Gen Intern Med. 2021 Dec;36(12):3830-3840. doi: 10.1007/s11606-021-06965-5. Epub 2021 Jun 25.

    PubMed 34173200

  • Clark LA, Watson D. Constructing validity: New developments in creating objective measuring instruments. Psychol Assess. 2019 Dec;31(12):1412-1427. doi: 10.1037/pas0000626. Epub 2019 Mar 21.

    PubMed 30896212

  • Doval E, Viladrich C, Angulo-Brunet A. Coefficient Alpha: The Resistance of a Classic. Psicothema. 2023 Feb;35(1):5-20. doi: 10.7334/psicothema2022.321.

    PubMed 36695846

  • Dunn TJ, Baguley T, Brunsden V. From alpha to omega: a practical solution to the pervasive problem of internal consistency estimation. Br J Psychol. 2014 Aug;105(3):399-412. doi: 10.1111/bjop.12046. Epub 2013 Aug 6.

    PubMed 24844115

  • Elsesser, K., & Sartory, G. (1998). OUTCOME PREDICTORS OF BENZODIAZEPINE WITHDRAWAL. Behavioural and Cognitive Psychotherapy, 26(3), 209-217. https://doi.org/10.1017/S135246589800023X

  • Gabauer J. CE: Mitigating the Dangers of Polypharmacy in Community-Dwelling Older Adults. Am J Nurs. 2020 Feb;120(2):36-42. doi: 10.1097/01.NAJ.0000654312.14385.3d.

    PubMed 31977416

  • Gehlert, S., & Ward, T. S. (2019). Theories of Health Behavior. In S. Gehlert & T. Browne (Éds.), Handbook of Health Social Work (1re éd., p. 143-163). Wiley. https://doi.org/10.1002/9781119420743.ch7

  • Gillespie R, Mullan J, Harrison L. Managing medications: the role of informal caregivers of older adults and people living with dementia. A review of the literature. J Clin Nurs. 2014 Dec;23(23-24):3296-308. doi: 10.1111/jocn.12519. Epub 2013 Dec 20.

    PubMed 24354583

Questions about this trial

What is this clinical trial studying?

An observational study of Psychological, run by Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stephan Van den Broucke, PhD (003210479046, stephan.vandenbroucke@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity and reliability of the measurement tool - HBQtD (time frame: Throughout the entire study, approximately during 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06212713, which also lists 59 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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