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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480062
First Posted: June 24, 2015
Last Update Posted: October 2, 2017
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.
Collaborators:
Wellcome Trust
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Public Health Foundation of India
  Purpose
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 Intervention
Hypertension Diabetes Depression Alcohol Use Disorder Other: mWELLCARE Other: Usual Care

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Public Health Foundation of India:

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

  • 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:
  • Depression [ Time Frame: Baseline and 12 months ]
    Proportion of patients with moderate and severe depression measured using PHQ-9 score

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

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

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

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

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

  • 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

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


Enrollment: 3702
Actual Study Start Date: April 2016
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
India
CHC Assandh
Assandh, Haryana, India, 132039
CHC Ballah
Ballah, Haryana, India, 132040
CHC Brara
Brara, Haryana, India, 133201
CHC Chauramastpur
Chauramastpur, Haryana, India, 134003
CHC Gharaunda
Gharaunda, Haryana, India, 132114
CHC Indri
Indri, Haryana, India, 132041
CHC Jhansa
Jhansa, Haryana, India, 136130
CHC Ladwa
Ladwa, Haryana, India, 136132
CHC Mathana
Mathana, Haryana, India, 136131
CHC Mullana
Mullana, Haryana, India, 133207
CHC Mustafabad
Mustafabad, Haryana, India, 133103
CHC Naharpur
Naharpur, Haryana, India, 135001
CHC Nilokheri
Nilokheri, Haryana, India, 132116
CHC Nissing
Nissing, Haryana, India, 132024
CHC Pehowa
Pehowa, Haryana, India, 136128
CHC Radaur
Radaur, Haryana, India
CHC Sadhaura
Sadhaura, Haryana, India, 133204
CHC Shahbad
Shahbad, Haryana, India, 136135
CHC Shahzadpur
Shahzadpur, Haryana, India, 134202
CHC Taraori
Taraori, Haryana, India, 132116
CHC Anandapuram
Anandapuram, Karnataka, India, 577412
CHC Anavatti
Anavatti, Karnataka, India, 577413
CHC Aynur
Aynur, Karnataka, India, 577221
Taluk Hospital Bhadravathi
Bhadravathi, Karnataka, India, 577301
CHC CN Halli
CN Halli, Karnataka, India, 572214
CHC Gubbi
Gubbi, Karnataka, India, 572216
CHC Holehonnuru
Holehonnuru, Karnataka, India, 577227
Taluk Hospital Hosanagara
Hosanagara, Karnataka, India, 577418
CHC Kannangi
Kannangi, Karnataka, India, 577226
General Hospital Koratagere
Koratagere, Karnataka, India, 572129
General Hospital Kunigal
Kunigal, Karnataka, India, 572130
CHC M.N.Kote
M.N.Kote, Karnataka, India, 572222
General Hospital Madhugiri
Madhugiri, Karnataka, India, 572132
General Hospital Pavagada
Pavagada, Karnataka, India, 561202
Taluk Hospital Sagar
Sagar, Karnataka, India, 577401
CHC Shiralkoppa
Shiralkoppa, Karnataka, India, 577428
General Hospital Sira
Sira, Karnataka, India, 572137
CHC Kannangi
Thirthahalli, Karnataka, India, 577432
General Hospital Tiptur
Tiptur, Karnataka, India, 572201
CHC Turuvekere
Turuvekere, Karnataka, India, 572227
Sponsors and Collaborators
Public Health Foundation of India
Wellcome Trust
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Dorairaj Prabhakaran Public Health Foundation of India
Principal Investigator: Vikram Patel London School of Hygeine and Tropical Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT02480062     History of Changes
Other Study ID Numbers: mWELLCARE 107/11
First Submitted: May 26, 2015
First Posted: June 24, 2015
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:
Chronic Disease
Disease Attributes
Pathologic Processes