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mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease (mWELLCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02480062
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : October 2, 2017
Sponsor:
Collaborators:
Wellcome Trust
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Public Health Foundation of India

Brief Summary:
Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Depression Alcohol Use Disorder Other: mWELLCARE Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Actual Study Start Date : April 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mWELLCARE software arm
The doctor and nurse care coordinators (NCCs) in the mWELLCARE intervention arm will be trained on the use of mWELLCARE software loaded on a tablet computer. Patients diagnosed with hypertension and/or diabetes will be registered by the nurse using mWellcare application. The nurse will record patient parameters, medical history, medication etc and generate a management plan (including drug recommendation, lifestyle advise) using the mWellcare application based on standard treatment guidelines. The doctor will review the recommendation and agree or disagree giving reasons. Patient will be followed up using SMS.
Other: mWELLCARE
mWELLCARE intervention arm will include a software application loaded on a tablet computer that will be used by Nurse Care Coordinators (posted in community health centers) in the course of their jobs to register patients with hypertension or diabetes, to generate clinical decision support recommendations, to track these patients over time and to improve follow-up care. Decision support recommendations will be printed and given to a doctor, who will make the final call on the management plan that will be used for the patient. Registered patients will also receive customized messages on their mobile phone. In addition, at sites where network connectivity permits, the doctor may also be equipped with a doctor's app on a tablet that will be largely the same as the NCC app.
Other Name: Software application loaded on a tablet computer

Active Comparator: Usual care arm
In the control arm or the usual care arm CHCs, the doctor and Nurse will get "refresher" training in the detection, management and follow up of hypertension and diabetes patients based on standard guidelines. They will be provided with charts for quick reference to standard treatment guidelines. Patients diagnosed with hypertension and/or diabetes will be managed by the doctor at the CHC. The nurse will assist in recording blood pressure, height, weight etc, providing lifestyle advise and follow up advice to patients.
Other: Usual Care
Usual care at the community health centers




Primary Outcome Measures :
  1. Systolic blood Pressure [ Time Frame: Baseline and 12 months ]
    Difference in mean change in systolic blood pressure between the two treatment arms

  2. Glycated haemoglobin (HbA1c) [ Time Frame: Baseline and 12 months ]
    Difference in mean change in glycated haemoglobin(HbA1c) between the two treatment arms


Secondary Outcome Measures :
  1. Depression [ Time Frame: Baseline and 12 months ]
    Proportion of patients with moderate and severe depression measured using PHQ-9 score

  2. Smoking [ Time Frame: Baseline and 12 months ]
    proportion of smokers

  3. Body Mass Index (BMI) [ Time Frame: Baseline and 12 months ]
    Difference in BMI

  4. Alcohol use [ Time Frame: Baseline and 12 months ]
    Change in alcohol use to be measured using WHO- AUDIT questionnaire

  5. Fasting blood sugar [ Time Frame: Baseline and 12 months ]
    Difference in mean change in fasting blood sugar

  6. Total cholesterol [ Time Frame: Baseline and 12 months ]
    Difference in mean change in total cholesterol

  7. CVD risk [ Time Frame: Baseline and 12 months ]
    Difference in mean change in predicted 10 year risk of cardiovascular disease using re-caliberated Framingham Risk Score

  8. Cost [ Time Frame: Baseline and 12 months ]
    Costs associated with delivering intervention compared to usual care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 30 yrs+ diagnosed with hypertension and /or diabetes who are able to give written consent (or verbal witnessed consent for illiterate patients).

Exclusion Criteria:

  1. Patient requiring immediate referral to tertiary care due to accelerated hypertension, diabetic complications.
  2. Patients with learning difficulties or vision/ hearing impairments but without a care giver making it impossible to use mobile phone.
  3. Pregnant and lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480062


Locations
Show Show 40 study locations
Sponsors and Collaborators
Public Health Foundation of India
Wellcome Trust
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Dorairaj Prabhakaran Public Health Foundation of India
Principal Investigator: Vikram Patel London School of Hygeine and Tropical Medicine

Additional Information:
World Health Organization, WHA 58.28 resolution text. 2005: Geneva.  This link exits the ClinicalTrials.gov site Curioso, W., New technologies and public health in developing countries: the Cell PREVEN project, in The Internet and health care: theory, research and practice, M. Murero and R. Rice, Editors. 2006, Lawrence Erlbaum Associates: Mahwah (NJ).  This link exits the ClinicalTrials.gov site Curioso, W. and P. Mechael, Enhancing 'M-Health' With South-To-South Collaborations. Health Affairs, 2010(29): p. 264-267.  This link exits the ClinicalTrials.gov site Vital Wave Consulting, mHealth for Development: The Opportunity of Mobile Technology for Healthcare in the Developing World. . 2009, UN Foundation-Vodafone Foundation Partnership: Washington, D.C. and Berkshire, UK.  This link exits the ClinicalTrials.gov site Hanson, K., et al., Expanding access to priority health interventions: a framework for understanding the constraints to scaling-up. J of International Development, 2003. 15(1): p. 1-14.  This link exits the ClinicalTrials.gov site Gerber, T., et al., An Agenda For Action On Global E-Health. Health Affairs, 2010. 29(2): p. 233-236.  This link exits the ClinicalTrials.gov site Blaya, J., H. Fraser, and B. Holt, E-Health Technologies Show Promise In Developing Countries. Health Affairs, 2010. 29(2): p. 244-251.  This link exits the ClinicalTrials.gov site Kaplan, W., Can the ubiquitous power of mobile phones be used to improve health outcomes in developing countries? . Global Health, 2006(2): p. 9.  This link exits the ClinicalTrials.gov site Rigby, M., Impact of telemedicine must be defined in developing countries. bmj, 2002. 324(7328): p. 47.  This link exits the ClinicalTrials.gov site Prince M, Patel V, Saxena S, Maj M, Maselko J, Phillips MR, et al. No health without mental health. Lancet. 2007; 370:859-77  This link exits the ClinicalTrials.gov site World Health Organization, Prevention of cardiovascular disease : guidelines for assessment and management of total cardiovascular risk. 2007: Geneva.  This link exits the ClinicalTrials.gov site mhGAP Intervention Guide for mental, neurological and substance use disorders in non-specialist health settings. ver 1.0. World Health Organisation Geneva, 2010.  This link exits the ClinicalTrials.gov site Free C, Phillips G, Watson L, Gallo L, Lambert F, Patel V, Edwards P. The Effectiveness Of Mobile Health Technologies for Improving Health and Health Services: A Systematic Review. Report for Department of Health, England (in preparation)  This link exits the ClinicalTrials.gov site

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT02480062    
Other Study ID Numbers: mWELLCARE 107/11
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Public Health Foundation of India:
Decision Support System
mHealth
Primary Health Care
Non-communicable diseases
Additional relevant MeSH terms:
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Chronic Disease
Alcoholism
Disease Attributes
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders