Thinking Outside the Box

NCT04713215 | Completed

• 2 other identifiers: 2899762782
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Medication adherence - the extent to which a patient takes their medications as prescribed - is a global problem. Half of all medicines given to patients with long-term health problems are not taken properly by the patient. Older adults are also more at risk of harm from their medications as they tend to take more medicines than young people, and are less able to cope with their effects. There has been research into how to address these problems. One way has been through providing patients with a medication compliance aid (MCA), to help with taking their medications on time. MCAs are pre-packaged boxes containing tablets, grouped together according to the day and time the medication needs to be taken. Some patients buy the MCA and fill it themselves, other patients collect a MCA that their pharmacy makes for them. There is not much proof that pharmacy-filled MCAs help patients, and some research suggests they may cause harm. The views of patients on MCA use have not yet been fully explored - it is not clear why some patients choose to stop using an MCA or refuse one when offered. Many patients with MCAs also have a family member or friend who helps them with their medication. No research has recognised the role of informal carers in helping patients with MCAs or asked them their thoughts. This study aims to understand what patients, aged 65 and older, and their informal carers think about MCAs and how they affect their lives. It is a questionnaire study which will take place within a National Health Service (NHS) hospital. It's designed to take approximately 20 minutes, either face to face or by phone. The investigators hope that the results from this study will help to inform how healthcare professionals use MCAs to the benefit of patients and their carers.

Conditions

Medication Compliance; Medication Adherence; Caregivers; Attitude

Keywords

Medication Compliance; Medication Adherence; Caregivers; Attitude

Outcome Measures

Primary Outcomes (1)

• To determine patients' and carers' opinions of medication compliance aids

  Through qualitative and quantitative analysis

  12 months

Secondary Outcomes (1)

• To determine whether those using MCAs would consider reverting to medicines in original packaging and what they might require to support this change.

  12 months

Study Arms (6)

Patients where MCAs are currently being used

Intervention: Patient questionnaire - Part A - patients where MCAs are currently being used

Other: Questionnaire

Patients where an MCA was discontinued

Intervention: Patient questionnaire - Part B - patients where an MCA was discontinued

Other: Questionnaire

Patients where an MCA was declined

Intervention: Patient questionnaire - Part C - patients where an MCA was declined

Other: Questionnaire

Carers where MCAs are currently being used

Intervention: Carer questionnaire - Part A - carers where MCAs are currently being used

Other: Questionnaire

Carers where an MCA was discontinued

Intervention: Carer questionnaire - Part B - carers where an MCA was discontinued

Other: Questionnaire

Carers where an MCA was declined

Intervention: Carer questionnaire - Part C - carers where an MCA was declined

Other: Questionnaire

Interventions

Questionnaire OTHER

A short (approximately 20-minute) questionnaire will be administered to patients and carers who meet the inclusion criteria and who have expressed and interested, and consented to completing the questionnaire.

Carers where MCAs are currently being used; Carers where an MCA was declined; Carers where an MCA was discontinued; Patients where MCAs are currently being used; Patients where an MCA was declined; Patients where an MCA was discontinued

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients aged 65 or over currently using an MCA * Patients aged 65 or over previously offered an MCA but discontinued * Patients aged 65 or over previously offered an MCA but declined * Informal carers (aged 18 or over) of patients aged 65 or over, currently using an MCA * Informal carers (aged 18 or over) of patients aged 65 or over, who were previously offered an MCA but discontinued * Informal carers (aged 18 or over) of patients aged 65 or over, who were previously offered an MCA but declined

You may qualify if:

• Patients currently using an MCA or patients previously offered an MCA but declined or discontinued
• Age 65 years or older
• English speaker
• Sufficient cognitive function to complete questionnaire
• A person who cares for someone aged 65 or older who is currently using a MCA or previously offered an MCA and declined or discontinued
• They assist the person they care for with their medication.
• Age 18 years or older
• English speaking
• Sufficient cognitive function to complete questionnaire

You may not qualify if:

• Age less than 65 years
• Lacks capacity to consent to participate in study
• Deemed by the direct clinical care team to be too unwell to participate
• Declines participation
• Age less than 18 years
• Employed to assist patient
• Not involved with medication management
• Lacks capacity to consent to participate in study
• Declines participation

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator
• Sir Halley Stewart Trust: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Thielemans L, Chin K, Hegarty A, Schiff R. Carer involvement in medication adherence: carer views and experiences of facilitating medication adherence using pharmacy-filled multi-compartment medication compliance aids and other methods of adherence support-a questionnaire survey. Age Ageing. 2023 Oct 2;52(10):afad169. doi: 10.1093/ageing/afad169.

  PMID: 37930740 RESULT

MeSH Terms

Conditions

Medication Adherence; Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rebekah Schiff, BSc, MBBS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: July 7, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 2, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)