Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website

Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website for Patients With Low Back Pain: a Study Protocol of a Randomised Controlled Trial

This project studies the effects of involving patients in the development of a web-application.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Information material

Detailed Description

The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Contacting general practice with low back pain

Exclusion Criteria:

• Spinal stenosis
• Spine fractures
• Cauda equina syndrome
• Spinal malignancy
• Osteoporosis
• Spondyloarthritis
• Without Danish reading skills
• Without internet access
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New web-application; Information material developed in a participatory design together with patients.	Other: Information material; Online web-application developed together with patients with low back pain
Experimental: Patient Handbook; Public available information.	Other: Information material; Online web-application developed together with patients with low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General satisfaction	The question: 'how likely is it that you would recommend this web-application to a friend or colleague?' will be applied to measure satisfaction. The patients will be asked to choose between 11 boxes displayed on a horizontal line (10-0 Points, higher score indicating more satisfaction). The scales will be labelled to the left at 10 (extremely likely) and at the right side as 0 (not at all likely). It is only possible to tick off one box, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Responses of 10-9 are grouped as 'satisfied' of the web-application and patients replying 8-0 will be grouped as 'not satisfied'. The proportion of patients being satisfied after 12 weeks is the primary analysis. The proportion of patients being satisfied after 1, 2, 4, and 8 weeks will be carried out as secondary analyses.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional improvement	Roland Morris functional disability score (RMDQ, the Patrick version, 0-23 points)	12 weeks
Pain intensity	Numerical pain rating of current pain (0-10 Points, rating from 'no pain' to 'maximal pain' )	1, 2, 4, 8, and 12 weeks
Improvement in self-rated health	EQ-5D-5L (EuroQol - 5 Diminsions - 5 Levels)	12 weeks
Employment status	Self reported current employment status (yes/no)	12 weeks
Sick leave	Self reported number of hours of sick leave during the study	12 weeks
Contacts to general practice	Self reported number of general practice contacts since study inclusion	12 weeks
Contacts to primary care physiotherapists	Self reported number of physiotherapy contacts since study inclusion	12 weeks
Contacts to primary care chiropractors	Self reported number of chiropractor contacts since study inclusion	12 weeks
Contacts to secondary care	Contact to secondary care because of low back pain during the study (yes/no)	12 weeks
Cost utility analysis	A analysis comparing the intervention group with the control group from a healthcare perspective. Including primary care costs such as public paid costs for GP contacts, physiotherapy services, and chiropractic services. Quality adjusted life years (QALYs) will be applied as measure of effect based on EQ-5D-5L. We will not include costs for developing and maintaining the new technology or other protocol driven costs. Based on the relative short time-horizon costs and effects will not be discounted.	12 weeks
Specific satisfaction	For further exploration of reasons for the primary outcome we include a question regarding the general satisfaction with the web-application (10-0) and detailed questions/items regarding satisfaction with design (very, some, little, none), satisfaction with customisation (very, some, little, none ), satisfaction with usability (very, some, little, none ), satisfaction with readability (very, some, little, none), and satisfaction with credibility (very, some, little, none). It is only possible to tick off one box to each item, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Furthermore, these items will be validated against the primary outcome.	1, 2, 4, 8, and 12 weeks

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: The Novo Nordic Foundation; The Danish Rheumatism Association
• Investigators: Principal Investigator: Allan Riis, PhD, Research unit for General Practice in Aalborg, Denmark

Publications and helpful links

General Publications

• Riis A, Rathleff MS, Hartvigsen J, Thomsen JL, Afzali T, Jensen MB. Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial). BMC Res Notes. 2020 Jan 10;13(1):24. doi: 10.1186/s13104-020-4894-8.
• Riis A, Hartvigsen J, Rathleff MS, Afzali T, Jensen MB. Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial). Trials. 2018 Jul 25;19(1):399. doi: 10.1186/s13063-018-2795-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: AllanRiis_4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No