Motivate: A Web-based Intervention

• Sponsor: Bournemouth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02777944
• Collaborator: Dorset HealthCare University NHS Foundation Trust (Other)
• Enrollment: 313
• Arms: 2
• Actual Duration (Months): 23

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders	Behavioral: Motivate: a web-based intervention	N/A

Detailed Description

MotivATE is a web-based intervention intended to be delivered at the point of referral to an Eating Disorder (ED) service. The 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. These modules have been evaluated by service-users who have an ED.

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.

Routine audit data will be collected to compare the number of people who attend their assessment appointment in the MotivATE group verses the control group. Usage data generated by the intervention will also be assessed. Twenty participants from the MotivATE group will be invited to give qualitative feedback about their experience of the intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 313 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Motivate: A Web Based Intervention to Increase Attendance at an Eating Disorder Service
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Access to Motivate: a web-based intervention, in addition to Usual Care	Behavioral: Motivate: a web-based intervention; 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.
No Intervention: Control Usual Care

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Attended Initial Assessment Appointment [3 months]

   Attendance at initial assessment appointment

Secondary Outcome Measures

1. Number of Participants Who Accessed the Intervention Program [3 months]

   Number of participants who accessed the intervention program

2. Number of Participants Who Volunteered to Provide Qualitative Feedback on the Motivate Program [3 months]

   Number of participants who volunteered to provide qualitative feedback on the Motivate Program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Referrals to the eating disorders service during the study period.

Exclusion criteria

1. Inpatients or emergency and urgent cases.

2. Patients who have already been randomised into the study.

3. Non English speakers

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bournemouth University
• Dorset HealthCare University NHS Foundation Trust

Investigators

• Study Director: Katherine M Appleton, PhD, Bournemouth University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 23, 2018

More Information

Publications

None provided.

• Responsible Party: Bournemouth University
• ClinicalTrials.gov Identifier: NCT02777944
• Other Study ID Numbers: PhDDay
• First Posted: May 19, 2016
• Last Update Posted: Aug 29, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Bournemouth University: motivation; attendance
• Additional relevant MeSH terms: Feeding and Eating Disorders

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	Access to Motivate: a web-based intervention, in addition to Usual Care Motivate: a web-based intervention: 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.	Usual Care
Period Title: Overall Study
STARTED	157	156
COMPLETED	157	156
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	Access to Motivate: a web-based intervention, in addition to Usual Care Motivate: a web-based intervention: 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.	Usual Care	Total of all reporting groups
Overall Participants	157	156	313
Age, Customized (Count of Participants)
Count of Participants [Participants]	0 0%
Sex/Gender, Customized (Count of Participants)
Count of Participants [Participants]	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United Kingdom	157 100%	156 100%	313 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Attended Initial Assessment Appointment
Description	Attendance at initial assessment appointment
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number of participants who attended initial assessment appointment

Arm/Group Title	Intervention	Control
Arm/Group Description	Access to Motivate: a web-based intervention, in addition to Usual Care Motivate: a web-based intervention: 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.	Usual Care
Measure Participants	157	156
Count of Participants [Participants]	140 89.2%	134 85.9%

2. Secondary Outcome

Title	Number of Participants Who Accessed the Intervention Program
Description	Number of participants who accessed the intervention program
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number of participants who accessed the intervention program

Arm/Group Title	Intervention	Control
Arm/Group Description	Access to Motivate: a web-based intervention, in addition to Usual Care Motivate: a web-based intervention: 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.	Usual Care
Measure Participants	157	0
Count of Participants [Participants]	53 33.8%	0 0%

3. Secondary Outcome

Title	Number of Participants Who Volunteered to Provide Qualitative Feedback on the Motivate Program
Description	Number of participants who volunteered to provide qualitative feedback on the Motivate Program
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Qualitative feedback on the intervention program

Arm/Group Title	Intervention	Control
Arm/Group Description	Access to Motivate: a web-based intervention, in addition to Usual Care Motivate: a web-based intervention: 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.	Usual Care
Measure Participants	53	0
Count of Participants [Participants]	2 1.3%	0 0%

Adverse Events

Time Frame	No data collected
Adverse Event Reporting Description	No data collected
Arm/Group Title	Intervention		Control
Arm/Group Description	Access to Motivate: a web-based intervention, in addition to Usual Care Motivate: a web-based intervention: 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.		Usual Care
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.