The U.S. National Institutes of Health has an online database called ClinicalTrials.gov that includes a registry of federally and privately supported clinical trials underway or completed. The database currently boasts more than 81,000 clinical trials from some 170 countries. As you might expect a couple dozen of those trials are testing wireless health solutions -- mostly mobile phone applications -- and their efficacy on health outcomes. MobiHealthNews rounded up 10 mobile phone-equipped clinical trials conducted by numerous academic institutions, world governments and big brand healthcare companies like AstraZeneca.
It is often said that wireless health solutions and healthcare mobile applications will not secure reimbursement or market uptake until they are proven to produce positive health outcomes. In the pages that follow, we have collected the studies underway or completed that are evaluating wireless health. Mine them for partners, processes and applications -- and be sure to give us your take on the solutions in these trials -- do they represent what's market ready? Do they point to the future of wireless health?
United Kingdom:A Mobile Phone Based Structured Intervention to Achieve Asthma Control in Patients With Uncontrolled Persistent Asthma: Pragmatic Randomised Controlled Trial
Principal Investigator:Dermot Ryan, University of Aberdeen
Although asthma outcomes can be improved with structured care, less than half of people with asthma achieve good control. Part of the problem is poor adherence with self-monitoring and preventive drug regimes. This trial will test whether using mobile phone-based monitoring, as part of a structured care plan, improves clinical outcomes and confidence in people with poorly controlled asthma.
Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to one of two groups. Those in the mobile phone group will monitor their asthma daily using their mobile phone to record symptoms, medication and lung function. Instantaneous feedback to their phone will provide a visual indication of asthma control and prompts about therapy. The patient and their clinician will have web-based access to all readings. People in the control group will use traditional paper-based monitoring. Under the care of their asthma nurse, both groups will be treated according to the step-wise approach of the BTS/SIGN asthma guideline in order to gain control.
We will use the validated Asthma Control Questionnaire to measure control at baseline, three and six months, and compare improvement in the two groups. We will also assess how confident people feel in controlling their asthma, using a validated measure of self-efficacy, attitudes and knowledge.
Estimated Enrollment:312
Study Start Date:November 2007
Estimated Study Completion Date:January 2009
Australia:A Randomised Controlled Trial Investigating a Mobile Phone Self-Monitoring Tool (Mobiletype) to Increase Emotional Self-Awareness and Reduce Depressive Symptoms in Young People.
Principal Investigators:Sylvia D Kauer, BBSci(Hons)Murdoch Childrens Research Instititue; Sophie C Reid, PhD, MPsychMurdoch Childrens Research Institute
The mobiletype program is a mental health assessment and monitoring tool that runs on mobile phones. The program assesses the general mental health of young people in real-time and transmits this data to a website to be reviewed by their general practitioner (GP) in consultation with their patient. The website consists of individualised feedback reports for each participant, and graphical displays of the monitoring data. The primary aims of the current project are to examine: (1) whether the process of self-monitoring via the mobiletype program increases young people's awareness of their mood and reduces depressive symptoms and (2) whether emotional self-awareness mediates the relationship between self-monitoring and depressive symptoms.
Device: Mobile Tracking Young People's Experiences (mobiletype) A mobile phone self-monitoring program, based on momentary sampling techniques, that prompts young people to complete it four times a day. The program asks several questions about daily activities, mood, stress, eating and exercise.
Estimated Enrollment:200
Study Start Date:February 2009
Estimated Study Completion Date:December 2010
Austria: Bacterial Contamination of Anaesthetists' Hands by Personal Mobile Phones Used in the Operating Theatre
Principal Investigator:Arnulf Benzer, MD, Medical University Innsbruck
The use of mobile phones in the operating room (OR) has become widespread, because of the lack of reports on serious problems. Since mobile phones are used in close body contact and since, as for most non-medical electronic equipment, there are no cleaning guidelines that meet hospital standards, the hygiene risk involved in using mobile phones in the OR has not yet been determined.
Estimated Enrollment:40
Study Start Date:January 2007
Study Completion Date:November 2007
United Kingdom:A Multinational, Randomised Study of the Efficacy of the Diabetes Interactive Diary (DID), a Carbohydrates/Insulin Bolus Calculator and a Telemedicine System Based on the Communication Between Physician or Dietitian and Patient by SMS
Principal Investigators: David Kerr, Doctor, Royal Bournemouth Hospital; Anita Bowes, Dietitian, Royal Bournemouth Hospital
For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed. We are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively. We are testing if "Diabetes Interactive Diary" (DID), a novel programme designed to be used on a mobile phone, can represent an important tool in carbohydrate counting while avoiding the use of complex calculations and in depth knowledge about the carbohydrate content of their food.
This is randomized control trial aimed to evaluate the effectiveness of a DID compare to the standard education approach in order to help the patients with Type 1 diabetes to estimate the carbohydrate in their food and adjust insulin doses. It involves individuals with Type 1 diabetes who are not habitually using carbohydrate counting. They should be testing their blood sugar levels at least 3 times a day, using multiple daily injections of short-acting and long-acting insulin analogues, with HbA1c between 7.5% and 10% and are familiar with the use of mobile phones and possess a personal SIM card.
Patients will be randomized to the standard education programme run for 4 full days over a 4 week period or to the DID programme run as three 2-hour sessions over a two-week period.
The DID is a novel software programme installed on the patient's mobile telephone. It facilitates the communication between the dietitian and the patient by using SMS text messages, so that the dietitian can monitor glycaemic control and suggest adjustments if necessary. It can be described as a little computer, where the patient can record their blood glucose value, the amount of insulin injected and the amount of carbohydrate consumed.
Enrollment:20
Study Start Date:March 2007
Study Completion Date:April 2008
United Kingdom:Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
Principal Investigator: University College London Professor Stanton P. Newman
Sponsors and Collaborators:University College London Hospitals; University College, London; Department of Health
New telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease. More recently the focus has been moving to portable systems equipped with Bluetooth. This study consists of evaluating an application called the Think Positive (T+) diabetes management software. It is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the T+ system. The objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined. Because of the supplementary real-time support and feedback that T+ offers, its use should lead to better outcomes in diabetes management than usual care does.
Estimated Enrollment:240
Study Start Date:August 2009
Estimated Study Completion Date:August 2012
Denmark:Assessment of the Health Related Effects of Compliance Optimization in Asthma Through Use of SMS (Short Message System) - A Controlled Trial
Principal Investigator:Claus Møldrup, PhDUniversity of Copenhagen
Sponsors and Collaborators University of Copenhagen; MedicoMonitor; The Ministry of Health and Prevention in Denmark
The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management.
Objective: The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.
Enrollment:244
Study Start Date:November 2007
Study Completion Date:May 2008
USA:Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text
Principal Investigator:Sheana Bull, PhD University of Colorado at Denver and Health Sciences
Sponsors and Collaborators: National Institute of Mental Health (NIMH)
This study will develop and test the effectiveness of a cell phone-based text messaging program to encourage abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.
Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a primary health issue, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this information, safe sexual practices, including correct condom use, are not commonly followed among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. A cell phone-based text messaging program designed to promote safer sex practices may provide an effective and easy means of delivery of treatment. This study will develop and test the effectiveness of a cell phone-based text messaging program to sustain abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.
Participation in this study will be divided into two phases. In the first study phase, participants will partake in a 90-minute focus group to help develop text message content and plans for treatment delivery. The next study phase will be a pilot test of the program developed in the first phase. Participants will be assigned to receive text messages concerning either HIV prevention or general nutrition. Participants receiving the HIV prevention text messages will be sent up to 90 text messages related to abstinence, monogamy, and condom use over a 3-month period. Participants will also be able to join interactive phone activities related to HIV. Participants receiving the nutritional text messages will be sent up to 30 messages about nutrition and healthy eating over the same period of time. Participants will complete telephone surveys at baseline and Months 3 and 6. The surveys will assess measures of abstinence, monogamy and condom use attitudes, norms, self-efficacy, and risk behaviors.
Estimated Enrollment:108
Study Start Date:October 2008
Estimated Study Completion Date:December 2010
Spain:Effect of Daily SMS Reminders on Medication Adherence to Oral Antipsychotics in Patients With Schizophrenia
Principal Investigator: N/A
Sponsors and Collaborators: AstraZeneca
This study is a 6-month, multicenter, randomized study to assess the effect of daily SMS reminders sent during 3 months in the adherence to oral antipsychotic treatment in stabilized outpatients with schizophrenia.
Estimated Enrollment:360
Study Start Date:April 2009
Estimated Study Completion Date:December 2009
Kenya:A Targeted Cell Phone Intervention to Improve Patient Access to Care and Drug Adherence in Patients Taking Antiretroviral (ARV) Medications in Kenya
Principal Investigator:Richard T Lester, MD, FRCPCUniversity of Manitoba
Sponsors and Collaborators: University of Manitoba, University of Nairobi
A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.
Enrollment:536
Study Start Date:May 2007
Estimated Study Completion Date:March 2010
India:The Role of Information Technology in the Prevention of Type 2 Diabetes
Principal Investigator:Ambady Ramachandran, M.D, D.ScPresident, India Diabetes Research Foundation and Chairman & Managing Director, Dr.A.Ramachandran's Diabetes Hospitals; Desmond Geoffrey Johnston, MB Ch B, Ph.D Professor of Clinical Endocrinology, Imperial College, London
Sponsors and Collaborators: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals, Imperial College, United Kingdom- India Education and Research Intiative(UKIERI), World Diabetes Foundation
Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it can be prevented in people at high risk by lifestyle intervention. While these trials established the proof of principle, they involved a degree of input from healthcare professionals not feasible outside the trial situation. We hypothesise that diabetes prevention can be achieved at lower cost using personalised feedback via mobile phone, based on information on body weight, diet and physical activity. We shall develop research protocols and computerised algorithms to test this hypothesis in India for application subsequently in the UK and elsewhere.
More:
The project will begin with the diabetes awareness campaign, using posters and pamphlets designed for the Indian population. Following implementation of the awareness campaign in selected workplace, employees will be selected for the prevention programme if they fulfil the following criteria: body mass index ≥ 23; age ≥ 35 years; a 1st degree relative with type 2 diabetes; and absence of other illness. The eligible subjects will undergo an OGTT with samples for glucose estimation at 0 and 2 hours. If the 2-hour plasma glucose level is > 7.8 - <11.1 mmol/l and/or the fasting glucose is >6.1 - <7.0 mmol/l, they will be selected for the project.
Participants will undergo randomization to either; the intervention group which will receive individualized feedback on lifestyle modification (diet and physical activity) by mobile phone or using their home computer; a control group which will receive conventional lifestyle advice.
The intervention group will be offered a mobile phone for the duration of the study (24 months). Their phone contract will be paid and payment will be provided for all calls and SMS messages sent or received for the purposes of the project. SMS messages will be sent each week and participants will be contacted monthly by voice, at times convenient to them, to discuss their progress and compliance with the behavioural modification. At 3 months, the participants in the intervention group will be contacted by phone and asked their views as to the frequency and mode of contact (SMS, voice contact or email). The advice will then be further individualized. The intervention group will have contact numbers for the investigators and may call or text at any time. The investigators will reply to messages within 48 hrs.
The participants will be seen baseline and at 6, 12, 18 and 24 months. Baseline assessments: Subjects will have a personal interview, complete a short health questionnaire and undergo a brief physical examination (including body weight, fat%,height, waist circumference, heart rate and blood pressure). They will complete questionnaires on diet and physical activity, quality of life and health care usage. A fasting blood sample will be taken for measurement of glucose, total and HDL-cholesterol, triglyceride, insulin, liver function, uric acid and other cardiovascular risk factors. An OGTT will be performed with samples for glucose and insulin estimation at 30 and 120 minutes. An ECG will be performed.
6 & 18 month assessments: Diet and physical activity questionnaires, body weight, WC, pulse and BP will be obtained. Two hour post prandial capillary glucose will be measured.
12 & 24 month assessment: Participants will be questioned about the acceptability of the project and its impact on their life. Changes in health will be documented and the physical examination repeated. They will complete further dietary, physical activity and quality of life questionnaires and will be asked about their use of healthcare resources for health economic assessment. The OGTT and ECG will be repeated, with other measurements as at baseline.
Estimated Enrollment:440
Study Start Date:March 2009
Estimated Study Completion Date:March 2012
To read more about these trials and to see a complete listing of clinical trials that have been or are using mobile phones as part of the intervention over at ClinicalTrials.gov
