NCT04935060

Brief Summary

The purpose of this study is to establish the acceptability of a guide developed to improve people's experiences of dementia assessment outcome appointments in comparison to a standard consultation. This study will also inform the feasibility of future research evaluating the guide and provide information on how well the measurements used provide evaluation of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

May 14, 2021

Last Update Submit

June 10, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Difference in scores on The Consultation and Relational Empathy (CARE) Questionnaire for each condition

    Measures patient and companions rating of clinician empathy in consultations. Higher scores suggest higher levels of clinician empathy. The maximum score possible is 50 and the minimum is 10.

    Baseline

  • Difference in scores on The Consultation and Relational Empathy (CARE) Questionnaire for each condition

    Measures patient and companions rating of clinician empathy in consultations. Higher scores suggest higher levels of clinician empathy. The maximum score possible is 50 and the minimum is 10.

    Post initial Consultation. Up to four weeks following consultation appointment.

  • Difference in scores on The Consultation and Relational Empathy (CARE) Questionnaire for each condition

    Measures patient and companions rating of clinician empathy in consultations. Higher scores suggest higher levels of clinician empathy. The maximum score possible is 50 and the minimum is 10.

    Post outcome appointment. Up to four weeks following outcome appointment.

  • Qualitative semi-structured interviews with patients and companions.

    Focussing on their experiences of the outcome appointment.

    Interviews to take place following the outcome appointment. Up to four weeks following outcome appointment.

  • Qualitative semi-structured interviews with clinicians.

    Focussing on their experiences of using the guide and delivering outcome appointments.

    Interviews to take place within four weeks of clilnicians completing outcome appointments with all of the patients participating in the study.

Study Arms (2)

Usual Care Dementia assessment

ACTIVE COMPARATOR

Clinicians will conduct the assessment and outcome process as per their usual practice.

Behavioral: Usual Care

Guide informed dementia assessment

EXPERIMENTAL

The guide will be used by both clinicians, patients and their companions to inform the approach to the dementia assessment process.

Behavioral: A guide to inform the process of delivering the outcomes of a dementia assessment

Interventions

The guide provides information that informs the approach taken to assessing people for dementia. It aims to guide clinicians. patients and their companions to think about how the diagnostic process is carried out, taking into account patient preferences, particularly around how they would like diagnostic decisions to be communicated to them.

Guide informed dementia assessment
Usual CareBEHAVIORAL

Clinicians conduct the dementia assessment as per standard protocols

Usual Care Dementia assessment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients will be included in the study if they are:
  • Taking part in an initial assessment appointment with the participating MAS services
  • Aged 18 years or over (Northamptonshire MAS require patients to be 65 years or over to be eligible for referral. There will be no upper age limit)
  • Able to provide written informed consent
  • Companions will be included in the study if they are:
  • Supporting a patient-participant to attend a MAS initial assessment appointment
  • Aged 18 years or over
  • Able to provide written, informed consent
  • MAS Clinicians will be included in the study if they are:
  • Involved in the delivery of MAS outcome appointments
  • Able to provide written informed consent

You may not qualify if:

  • Patients and companions will not be included in the research if there is reason to doubt their capacity to give informed consent under the Mental Capacity Act 2005.
  • Patients and companions who are not fluent in English will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memory Assessment Service (Corby/Kettering)

Corby, Northamptonshire, NN17 1RJ, United Kingdom

Location

Memory Assessment Service (Rushden/Wellingborough)

Rushden, Northamptonshire, NN10 0PT, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Danielle De Boos

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2021

First Posted

June 22, 2021

Study Start

September 21, 2021

Primary Completion

May 4, 2022

Study Completion

May 4, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations