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
See additional files
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
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30578185
Publication citations
Additional files
- ISRCTN98629372_PIS_11May18.pdf Uploaded 02/04/2019