NCT02777944

Brief Summary

The aim of this study is to test whether MotivATE can increase attendance at assessment. This will be done using a single-consent Zelen randomised control trial, with all non-emergency adult clients referred to the Kimmeridge Courte Eating Disorder Service over a one year period being randomised to either treatment as usual (TAU) or TAU plus access to the MotivATE intervention prior to their assessment appointment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

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

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 31, 2019

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

May 17, 2016

Results QC Date

July 23, 2018

Last Update Submit

August 14, 2019

Conditions

Keywords

motivationattendance

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Attended Initial Assessment Appointment

    Attendance at initial assessment appointment

    3 months

Secondary Outcomes (2)

  • Number of Participants Who Accessed the Intervention Program

    3 months

  • Number of Participants Who Volunteered to Provide Qualitative Feedback on the Motivate Program

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Access to Motivate: a web-based intervention, in addition to Usual Care

Behavioral: Motivate: a web-based intervention

Control

NO INTERVENTION

Usual Care

Interventions

A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules.

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) Referrals to the eating disorders service during the study period.

You may not qualify if:

  • Inpatients or emergency and urgent cases.
  • Patients who have already been randomised into the study.
  • Non English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Denison-Day J, Muir S, Newell C, Appleton KM. A Web-Based Intervention (MotivATE) to Increase Attendance at an Eating Disorder Service Assessment Appointment: Zelen Randomized Controlled Trial. J Med Internet Res. 2019 Feb 27;21(2):e11874. doi: 10.2196/11874.

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Limitations and Caveats

Use of only one site limits the applicability of the findings to general practice. Lack of a pre-post measure of motivation to change. Potential lack of power in the analysis of the primary research question.

Results Point of Contact

Title
Prof. Katherine Appleton
Organization
Bournemouth University

Study Officials

  • Katherine M Appleton, PhD

    Bournemouth University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

September 1, 2018

Last Updated

August 29, 2019

Results First Posted

July 31, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Group data will be publicly available on completion