The aim of the present study was to investigate usability aspects of DBS patient controllers and the impact of hands-on training with and without the combination of age-specific video instructions in elderly DBS patients with movement disorders. The most important results are as follows:
-
1)
After having seen the video-based training, patients solved many tasks on the model IPG significantly better than the control group. Significant differences were found in opening the lid of the controller, naming the correct type of 9 V battery, identifying the icon of the IPG battery and knowing the meaning of single and triple acoustic signals.
-
2)
A six months, the video group still outperformed the control group indicating that age-specific video instructions and hands-on training have more beneficial effects on usability aspects than interactive training alone.
-
3)
The video group also performed faster than the control group at both assessments.
-
4)
At the second assessment, the control group was faster than it was at baseline and but still made similar errors as before. The most common mistakes were opening the cover of the controller and knowing the meaning of the IPG battery. This implies that there were slight learning effects within the control group, probably induced by the presentation order of the interactive assessment with the dummy IPG at baseline. However, this difference was not significant compared to the effectiveness of the video-based training.
-
5)
Patients have hardly any caregiver support when it comes to using the DBS controller.
-
6)
In general, half of our patients used the therapy controller too infrequent for checking the battery status of the IPG at baseline. Six months later two thirds used it regularly. This difference was not significant, probably due to the small sample size.
The results show that patients, who have been using the device for several years, still have many difficulties and uncertainties. These results imply that hand-held patient controllers are not very intuitive and require improvement in usability aspects for end-users. However, we also demonstrated that the use of an age-specific video-based training has beneficial effects on the performance of patients. Right after watching the video, patients made fewer errors on a dummy IPG than patients who had not seen the video instructions. After a six months retention interval this difference was still present. Thus, appropriate training may lead to a more confident interaction with technical products, even if they do not entirely meet the needs of the end-users and even if this intervention did not have any influence on the patients' attitude towards the device.
Mykityshyn et al. [7] also found video instructions to be superior to text-based user manuals for this age group. Up until now, patients using the Access patient controller only receive a written user manual. Physicians personally explained the device to our patients at the end of their hospitalization after electrode placement or sometimes also if patients had specific questions during a follow-up visit. Apparently, this unsystematic approach was not enough. In the future, additional effective and age-specific video material and greater personal helpdesk may be preferable to support elderly patients to learn how to correctly use DBS controllers. Some clinics offer the support of specialized Parkinson's or DBS nurses to train the patients on the therapy controller. However, the availability of such specialized nurses is by far not everywhere ensured. Even if patients receive sufficient personal helpdesk by a DBS nurse at the clinic, video instructions may support them at home if questions arise. Operating the controller incorrectly may provoke acute physical interventions on the body and may lead to fear of use in those who do not feel entirely competent in using the device. Additional video material that can be watched over and over again may support and encourage patients to use the therapy controller in daily life, when there is no support from the clinic. This is especially valid for patients who live in remote areas and, as mentioned above, for those who have no access to DBS nurses.
Video modeling or observational learning may be crucial to improve the understanding of how to use a technical devices [8] but also to increase self-efficacy and self care and reduce anxiety in educating patients regarding treatment options [14]. As rechargeable DBS systems are being established on the market, usability aspects and appropriate training options become even more important because patients need to take a much more active part in their aftercare that patients with primary cell systems.
In our previous work [2] we have already pointed out the gerotechnological strengths and weaknesses of DBS patient controllers. With advanced age, decrements occur i.a. in the perception of short wave length colors such as blue. In the Medtronic Access controller, the on- and off-keys are very narrowly located to each other and have the same blue color, which makes confusion bound to occur. As on- and off-keys usually are presented in signal colors such as green or red, respectively, the blue coloring of the buttons goes against general mental models and expectancies [15]. Visual impairments that come with normal aging also require good contrast ratio on technical devices [15]. However, the contrast between the buttons and the grey housing of the controller is relatively poor (see Figure 4). This is also valid for contrast ratio of the icons of the buttons. Most importantly, the control group did not recognize the IPG icon. This symbol is depicted on the on- and off-keys as well as three times on the backside of the controller next to the control lights. The IPG icon may not be self-explanatory, as the majority of patients have never seen a pulse generator, which is implanted under their skin. Previous studies have shown that signs and symbols increase the speed of information processing, given that subjects have had the opportunity to learn their meaning [15].
As the controller has no display, patients have to count and remember the steps when they alter their stimulation settings, which may be a problem with respect to cognitive load. This is even more important considering the fact that many PD patients develop cognitive impairment in the course of their disease [16].
The Access therapy controller only communicates via high frequency sounds. The ability to perceive high frequencies also declines with normal aging [3]. Our results show, that the control group had difficulties to identify the meaning of a single and triple beep at baseline (assignment 7). Thus, after several years of using the controller, they did not entirely understand the only possible means of communication of the device. However, after six months there was no significant difference between groups anymore, probably due to task presentation that included various repetitions. After assignment 7, patients were asked to either increase or decrease the stimulation on the dummy IPG and again to identify the meaning of the emitted acoustic sounds. Hence, although patients of the control group had not seen the video-based training, they actively learned by the specific presentation order, albeit slower.
Compared to the video group, patients of the control group had greater difficulties in opening the cover of the therapy controller at both assessments. In practice, many patients did not find the correct release mechanism of the lid but tried to open it by squeezing on the both sides of the device. The release mechanism in its present form might go against expectancies and mental models of elderly patients.
The control group also had problems in identifying the correct name of the nine-volt battery that is used in the therapy controller. If the battery of the controller is low, patients need to change it themselves. On the backside of the therapy controller there is a control light with an icon showing a nine-volt battery. Thus, it is important for patients to know the meaning of it. The reason for the poorer performance of the control group may be due to the fact that nine-volt batteries are hardly ever used in hand-held devices such as TV remotes. Hence, common mental models and expectations may have been violated. The other group was confronted several times with this kind of battery in the video instructions and thus performed better.
Assuming that a depleting IPG battery is completely drained after more than a month, our results show that at baseline about half of the patients were at risk to experience sudden therapy loss and that caregivers barely use the controller. After six months the amount of all patients who checked the IPG battery in time increased up to two thirds. Probably due to small sample size, this difference was not significant. However, our data show that patients tend to use therapy controller on an irregular basis.
Our study has limitations due the relatively small series of patients. In the future more research should be done on larger patient samples and also for a longer period of time. Also the rater was not blinded. However, due to the given comparability of groups and the objective criteria at the nine assignments that the patients had to complete, the results seem to be robust.
Our results also show that patients change their neuromodulation settings very rarely. About half of the patients hardly ever change their parameters. If patients would feel more confident when operating the controller, they would probably make more often use of its advantages and adjust their settings according to their daily constitution. As it is not vital to adjust the stimulation settings on a regular basis, there should be other incentives like emotional design features to make using the controller more attractive to patients. Improved usability is even more important, considering that patients are left on their own when it comes to using the therapy controllers. The majority of the participants of our study stated that they have hardly any caregiver support.
Significant results were found in task completion time. Both groups significantly improved their performance at the second assessment compared to baseline. At both points in time, the video group was faster than the control group. This difference, however, was not significant, probably also due to small sample size. The learning effects of both groups indicate the positive impact of any kind of personal help desk, which should be provided in the clinics' routine.