The goal of this pilot study is to assess the usability and preliminary effects on treatment outcomes of an mHealth application supplementary to SET for patients with intermittent claudication. Furthermore, we aim to determine the reliability,…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is usability and will be assessed through the system
usability scale and semi-structured interviews.
Secondary outcome
Secondary endpoints include the effect of the app on symptom severity
(treadmill tests, six-minute walk test, vascular quality of life questionnaire
6, walking impairment questionnaire) and daily physical activity. The novel
smartphone-based measurements of walking impairment will be assessed by
determining their variability and test-retest reliability, agreement with
conventional functional tests and patient-reported outcome measures, and
response to 12 weeks of SET.
Background summary
The effectiveness of supervised exercise therapy (SET) for intermittent
claudication (IC) regarding reduction of symptoms and improvement of
(health-related) quality of life is well established. However, despite its
effects on symptomatology, SET programs only moderately stimulate healthy
behaviour in daily life. Furthermore, conventional outcome measures in IC
provide a poor reflection of walking impairment in daily life.
Study objective
The goal of this pilot study is to assess the usability and preliminary effects
on treatment outcomes of an mHealth application supplementary to SET for
patients with intermittent claudication. Furthermore, we aim to determine the
reliability, applicability and agreement with the most used functional tests
and patient-reported outcome measures of a novel smartphone-based measurement
of walking impairment in patients with IC.
Study design
Single-arm pilot study.
Intervention
A patient-centred mHealth smartphone app integrated with SET. The app enables
patients to conduct smartphone-guided home-training sessions and set goals and
monitor progress regarding walking capacity and daily physical activity.
Study burden and risks
The novel component of the study intervention is a secured online
patient-centred smartphone app. This intervention can be beneficial for
participants as it aims to improve healthy behaviour. Interacting with the app,
e.g. being prompted to start home-training sessions, can possibly burden
patients. Risks of the intervention are low; SET is a safe treatment and proper
physical and digital security for sensitive data is ensured conform to NEN 7510
standards, which is a Dutch extension of the international ISO 27001. The
application does not measure, nor provide feedback regarding, vital parameters.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Diagnosis of intermittent claudication (symptomatic peripheral arterial disease, Rutherford stage 1-3, Fontaine 2a-2b) evidenced by a resting ankle-brachial index of *0.9 in rest and/or a drop of >0.15 after treadmill walking in either leg.
- In possession of a smartphone capable of running the intervention application.
- A signed informed consent form.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Supervised exercise therapy, performed in accordance with the guidelines of the Dutch Society of Physical Therapy, in the 12 months prior to study enrolment.
- The ability to finish the Gardner Skinner treadmill test (i.e. walk for >30 minutes, or >1600 meters).
- Severely limited ambulation due to a cause other than intermittent claudication (e.g. above or below the knee amputation, critical limb ischemia, wheelchair confinement, foot ulcer, significant visual impairment, unstable angina, heart failure NYHA class II or greater, COPD GOLD 3-4) and/or the inability to frequent the physical therapy centre at the expected visit frequency.
- Deemed a poor candidate for inclusion at the discretion of the physical therapist or principal investigator.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL63118.100.17 |