A Mobile App for Chronic Disease Self-Management for Individuals with Low Health Literacy: A Multisite Randomized Controlled Clinical Trial

Round 1

Reviewer 1 Report

This paper reports the findings of a clinical trial to explore the effects of a mobile app to improve self management among adults with chronic conditions, with a particular focus on health literacy. The paper is well written, follows a clear structure and presents the study findings clearly and concisely.  I am happy to recommend the paper for publication and have made minor suggestions for improvement.

In the introduction, the authors present the facts concerning low levels of health literacy in the US and also across the globe to make the case for interventions to improve health literacy.  The mobile app discussed is then put forward as one example of working towards this.  This is all very clear, however, the ap is designed for people who already have chronic conditions and thus is a responsive tool following diagnosis of a chronic condition and so can only go so far to address health literacy because the individuals using it in the trial will already have utilised a certain degree of health literacy that has resulted in the help seeking (recognising bodily signs and symptoms of disease and knowing where to go for appropriate diagnosis) that came before their diagnosis.  I don't see this as a major issue at all, but, I do think it is worth the authors aknowledging this and adding a few reminders throughout.  The sentence that begins on line 58, for example, could end with 'among people diagnosed with chronic conditions'.  I think the sentence that starts on line 137 and ends on line 40, addressing why CDSM was chosen as the target audience for the ap would be better placed in the intro to help with this clarification.  The choice of CDSM works well alongside the variables the authors have chosen to monitor and this focus lends itself well to the methodology used.

I think a weakness in the app development process is that it didn't include patients with low health literacy.  While potential users were included in the usability testing phase, I wonder why they weren't included in the development phase too? As far as I can see from the content of the paper only 'professionals' were included in this process.  I suggest the authors address this in the limitations section.  Patient input into the app development would have added valuable insight and may have resulted in different content to that that was finalised.  As it stands the decision making about app content followed a top down process where users were only consulted once content had been made.  While users had the chance to change this, their input at the beginning would have added value.

The authors justify why people age 40 and over were consider eligible for the study and I think this works well.  However, i am not sure that the use of 'older people' throughout works well.  The mean age of participants was middle to late 50s.  I suggest replacing this with something like 'from middle age onwards' or something to more accurately reflect the age demographic of the participants involved.

The study shows a number of potential benefits to patients with chronic diseases that require self-management.  There is no discuss of future intentions.  I am left wondering about this.  Was the intention to show that apps are good for CDSM or was the intention to show that this particular app is good for CDSM?  If the latter, are there plans for further development?  It would be useful if the authors could clarify this in a short paragraph within the conclusion.

From the conclusion it seems that there are plans for future development of the app.  I wonder if it might be useful to include a short paragraph to outline future plans? i.e. things that will be explored/developed.  Something that strikes me is the feasibility of patient use of the app or using the app with patients in the future – it seems very time intensive and it appears that staff resource is required to facilitate use.  I also wondered about uptake.  If the app is not free of charge this will limit uptake to those who can afford it/those who choose to spend their money in this way.  These issues are beyond the scope of the paper but I thought I would share them as these are the things that the paper left me thinking about. 

Author Response

Line numbers of changes are included for both the track changes version of the MS and the version with changes accepted. Reviewer comments are included in italic font, with response in regular font.

This paper reports the findings of a clinical trial to explore the effects of a mobile app to improve self management among adults with chronic conditions, with a particular focus on health literacy. The paper is well written, follows a clear structure and presents the study findings clearly and concisely.  I am happy to recommend the paper for publication and have made minor suggestions for improvement.

 We thank the reviewer for this positive evaluation.

In the introduction, the authors present the facts concerning low levels of health literacy in the US and also across the globe to make the case for interventions to improve health literacy.  The mobile app discussed is then put forward as one example of working towards this.  This is all very clear, however, the ap is designed for people who already have chronic conditions and thus is a responsive tool following diagnosis of a chronic condition and so can only go so far to address health literacy because the individuals using it in the trial will already have utilised a certain degree of health literacy that has resulted in the help seeking (recognising bodily signs and symptoms of disease and knowing where to go for appropriate diagnosis) that came before their diagnosis.  I don't see this as a major issue at all, but, I do think it is worth the authors aknowledging this and adding a few reminders throughout. 

We have added the suggested reminders in the MS at lines 203-206 and lines 564-566 (in MS with changes accepted, lines 565-567).

The sentence that begins on line 58, for example, could end with 'among people diagnosed with chronic conditions'.  

We have added phrase as suggested, now at lines 66-67.

I think the sentence that starts on line 137 and ends on line 40, addressing why CDSM was chosen as the target audience for the ap would be better placed in the intro to help with this clarification.  

We have moved the sentence as the reviewer suggests and it is now at lines 131-137 (130-136 in MS with changes accepted).

The choice of CDSM works well alongside the variables the authors have chosen to monitor and this focus lends itself well to the methodology used.

 We agree.

I think a weakness in the app development process is that it didn't include patients with low health literacy.  While potential users were included in the usability testing phase, I wonder why they weren't included in the development phase too? As far as I can see from the content of the paper only 'professionals' were included in this process.  I suggest the authors address this in the limitations section.  Patient input into the app development would have added valuable insight and may have resulted in different content to that that was finalised.  As it stands the decision making about app content followed a top down process where users were only consulted once content had been made.  While users had the chance to change this, their input at the beginning would have added value.

Persons from a wide variety of backgrounds were involved in the development of the app from the beginning, as they participated in a qualitative study that preceded the translation of topics in chronic disease self-management into the app (reference #70) and were involved in the app development process during usability testing, during which their feedback about app content was elicited.  We regret that this was not clear in the original MS and have revised the methods section to make this clearer (lines 148-150). We agree that a more interactive development process might have yielded different content, and have added this as a limitation in the discussion (lines 573-576; lines 567-570 in MS with changes accepted).

The authors justify why people age 40 and over were consider eligible for the study and I think this works well.  However, i am not sure that the use of 'older people' throughout works well.  The mean age of participants was middle to late 50s.  I suggest replacing this with something like 'from middle age onwards' or something to more accurately reflect the age demographic of the participants involved.

We have changed the wording as the reviewer suggests, adopting the suggested language or using the wording “40 years of age and older” (multiple instances).

The study shows a number of potential benefits to patients with chronic diseases that require self-management.  There is no discuss of future intentions.  I am left wondering about this.  Was the intention to show that apps are good for CDSM or was the intention to show that this particular app is good for CDSM?  If the latter, are there plans for further development?  It would be useful if the authors could clarify this in a short paragraph within the conclusion.

We have added a paragraph in the conclusion addressing these issues.

From the conclusion it seems that there are plans for future development of the app.  I wonder if it might be useful to include a short paragraph to outline future plans? i.e. things that will be explored/developed.  Something that strikes me is the feasibility of patient use of the app or using the app with patients in the future – it seems very time intensive and it appears that staff resource is required to facilitate use.  I also wondered about uptake.  If the app is not free of charge this will limit uptake to those who can afford it/those who choose to spend their money in this way.  These issues are beyond the scope of the paper but I thought I would share them as these are the things that the paper left me thinking about. 

We have expanded the conclusion to address these issues (lines 597-601; 588-593 in MS with changes accepted).

Reviewer 2 Report

The study examined the effects of the CDSM mobile application on 564 elderly people with low health literacy and chronic illnesses. The study examined the use of applications at the level of 8th, 5th and 3rd graders in the treatment of a self-inflicted long-term illness. The concept of using the app is very interesting and most likely very much needed now and in the future.

Targeting the review to the elderly is special, because already 40-year-olds are designated as elderly. To my understanding 40 is not older people. The problem with the focus seems also to be that chronic diseases are not limited in any way, but variety of chronic diseases are accepted. There is evidence that, for example, committing to treatment and making lifestyle changes for heart and vascular diseases is generally more difficult than for diseases of the respiratory system. Thus, a more precise delimitation could have made the analysis of the research results and the conclusions clearer than at present. Furthermore, the fact that the App has only been tested with certain ethnic groups makes the setup questionable in that respect. When all the choices are better reasoned, it probably could make better sense.

However, I believe that the development of the application is important and that a more precise justification of the focuses of the aforementioned research gives credibility to the results of this research. As explained at the end of the study, the subsequent development of the application will include additional analyzes and specify which target group the app is potentially suitable for.

Author Response

Line numbers of changes are included for both the track changes version of the MS and the version with changes accepted. Reviewer comments are included in italic font, with response in regular font.

The study examined the effects of the CDSM mobile application on 564 elderly people with low health literacy and chronic illnesses. The study examined the use of applications at the level of 8th, 5th and 3rd graders in the treatment of a self-inflicted long-term illness. The concept of using the app is very interesting and most likely very much needed now and in the future.

 We agree.

Targeting the review to the elderly is special, because already 40-year-olds are designated as elderly. To my understanding 40 is not older people.

The MS has been revised to better characterize the age group involved in the study as also suggested by reviewer 1.

The problem with the focus seems also to be that chronic diseases are not limited in any way, but variety of chronic diseases are accepted. There is evidence that, for example, committing to treatment and making lifestyle changes for heart and vascular diseases is generally more difficult than for diseases of the respiratory system. Thus, a more precise delimitation could have made the analysis of the research results and the conclusions clearer than at present.

We agree with the reviewer that the challenges in managing some diseases are greater than those in managing others. We also agree that this is an issue but would suggest that it is inherent in our and others’ approach to chronic disease self-management as it focuses on problems that are not disease-specific (e.g., sleep disturbance, low mood, stress) rather than problems related to specific diseases. In response to the reviewer, in the discussion section we have noted this as a limitation that may be further explored in future analyses (lines 579-561; 588-593 in MS with changes accepted).

Furthermore, the fact that the App has only been tested with certain ethnic groups makes the setup questionable in that respect. When all the choices are better reasoned, it probably could make better sense.

We agree that this is a limitation and have further clarified this as a limitation in the discussion (lines 572-574; 563-565 in MS with changes accepted).

However, I believe that the development of the application is important and that a more precise justification of the focuses of the aforementioned research gives credibility to the results of this research. As explained at the end of the study, the subsequent development of the application will include additional analyzes and specify which target group the app is potentially suitable for.

We agree that in spite of significant limitations of the study, ongoing the development of the app is important.  We have further clarified plans for future development in the paragraph added to the conclusion in response to the suggestions of reviewer 1.

Round 2

Reviewer 2 Report

That article is now good and can b published as it it.