Condition category
Musculoskeletal Diseases
Date applied
30/04/2018
Date assigned
13/05/2018
Last edited
11/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Modern healthcare focuses on shared decision making (SDM). SDM is the process in which both the doctor and the patient decide on the best treatment, taking into account medical factors as well as patients’ preferences. In order to be able to participate in the process of SDM, patients need to have knowledge about the subjects they are discussing with their doctor. Currently patients are mainly educated about their illness and the available treatment options during the consultation with the doctor. Unfortunately, this has proven to be an ineffective way to improve their knowledge.
Factors that make it difficult for the patient to absorb information from the doctor include age, level of education of the patient, lack of time available, complex language from the doctor and above all, too much information in too little time.
This study aimed to investigate whether providing patients with 'bite-size', categorised and interactive content through an app for smartphone or tablet could increase their knowledge about their illness and treatment options.

Who can participate?
Patients with knee osteoarthritis, who were referred to the hospital by their general practitioner.

What does the study involve?
In the week before the consultation, patients in the app group received information on a daily basis. The information was about 5 important topics that would be addressed in the consultation with the orthopedic (joint) surgeon: about the knee and osteoarthritis, conservative (non-invasive) treatment, surgical treatment, rehabilitation and expectations. Patients were actively offered the information through push notifications. Each topic was available in text, images and a short video. Each topic had quiz-like questions to, on a day-to-day basis, measure (and reflect) on patients’ knowledge about the topic.

What are the possible benefits and risks of participating?
There are no risks of participating. People in the app group might gain a better understanding of knee osteoarthritis and options for treatment.

Where is the study run from?
Several medical centres in the Netherlands

When is the study starting and how long is it expected to run for?
April 2017 to September 2017

Who is funding the study?
The maker of the app, Interactive Studios

Who is the main contact?
Thomas Timmers, thomas@interactivestudios.nl

Trial website

Contact information

Type

Public

Primary contact

Mr Thomas Timmers

ORCID ID

http://orcid.org/0000-0002-2534-5799

Contact details

Huisbergenweg 6
Rosmalen
5249JR
Netherlands
0031 73 644 6069
thomas@interactivestudios.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N16.130

Study information

Scientific title

Assessing the efficacy of an educational smartphone or tablet app with subdivided and interactive content to increase patients’ medical knowledge: A randomized controlled trial

Acronym

Study hypothesis

Providing patients with medical information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet increases the knowledge about their illness and the treatment options

Ethics approval

Medical Ethical Board Maxima MC (Eindhoven, The Netherlands), 18/10/2016, N16.130

Study design

Surgeon-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Knee osteoarthritis

Intervention

A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to one of the six Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis (OA). The eligibility of patients was assessed during their first contact with the hospital to schedule their appointment with the orthopedic surgeon. One group of patients were randomly allocated to use an interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week prior to their consultation with the orthopedic surgeon. Patients received, on a daily base and by means of push notifications, information about one of the following topics: the knee and the origin of the complaints, conservative treatment, surgical treatment, risks, rehabilitation after discharge and expectations. Each day covered one topic. Video, images and text were used as modes of information. Quiz-like questions were asked after each video to provide direct feedback of patients' understanding of the information.
Patients in the control group did not receive the app. They had access to all the standard information (eg. website, brochure) that is normally offered to them in the period prior to the consultation.
After accepting participating in the study, patients were automatically online randomised. No blocks or clusters were used.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Patients' knowledge (perceived and actual) about their illness and the treatment options. Actual knowledge was measured 2 days prior to the consultation by a 12-item multiple choice questionnaire, with possible scores ranging from 0 to 36. Perceived knowledge was also measured 2 days before the consultation by a 5-item multiple choice questionnaire, with possible scores ranging from 0 to 25.

Secondary outcome measures

1. Satisfaction with information and patient knowledge was measured 2 days before the consultation by using NRS scores ranging from 0 to 10
2. Certainty of the treatment chosen was measured 1 day after the consultation using an NRS 0 to 10 scale.

Overall trial start date

01/04/2017

Overall trial end date

01/09/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Referred by GP to orthopedic surgeon for suspected knee osteoarthritis
2. Fluent in Dutch
3. Possess an email address and a smart phone or tablet
4. At least 10 days between scheduling the appointment and the hospital visit were required, to give patients in the app group the chance to experience the intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

188

Participant exclusion criteria

1. Not Dutch-speaking
2. Not in possession of smartphone or tablet

Recruitment start date

01/04/2017

Recruitment end date

01/08/2017

Locations

Countries of recruitment

Netherlands

Trial participating centre

VieCuri Medical Centre,
Venlo
5912BL
Netherlands

Trial participating centre

Kliniek ViaSana
Mill
5451AA
Netherlands

Trial participating centre

Jeroen Bosch Ziekenhuis
Den Bosch
5223GZ
Netherlands

Trial participating centre

Canisius-Wilhelmina Hospital
Nijmegen
6532SZ
Netherlands

Trial participating centre

Sint Anna Ziekenhuis
Geldrop
5664EH
Netherlands

Trial participating centre

Amphia Hospital
Breda
4818CK
Netherlands

Sponsor information

Organisation

Interactive Studios

Sponsor details

Huisbergenweg 6
5249 JR
5249JR
Netherlands
0031736446069
thomas@interactivestudios.nl

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

Interactive Studios

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The data is available to the researchers from the participating hospitals upon request. They can request that data through the main investigator, Thomas Timmers. They can only access the data from their own patients. Data is provided in an encrypted Excel or SPSS file. In the files (and the complete data collection system) only data is available from patients that gave their informed consent.

Intention to publish date

01/06/2018

Participant level data

Not provided at time of registration

Basic results (scientific)

In total 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 versus 17.4, P <0.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P < 0.001), compared to no gain in the control group.

Publication list

Publication citations

Additional files

Editorial Notes