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Clinical Trials/ISRCTN41238563
ISRCTN41238563
Completed
未知

Randomized controlled trial of a mobile phone-based telemonitoring application for self-management and clinical decision support for patients with complex chronic conditions

niversity Health Network0 sites96 target enrollmentAugust 9, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Heart failure (HF), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), uncontrolled hypertension, diabetes
Sponsor
niversity Health Network
Enrollment
96
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29162557 protocol 2021 Preprint results in https://doi.org/10.2196/31754 results in preprint (added 20/12/2021)

Registry
who.int
Start Date
August 9, 2016
End Date
November 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Health Network

Eligibility Criteria

Inclusion Criteria

  • All participants:
  • 1\. Adults (age 18 years or older)
  • 2\. Diagnosed with HF, COPD, CKD, and/or uncontrolled hypertension (individuals with diabetes who require blood glucose monitoring will be included as a co\-morbidity only if patients have at least one of the above four chronic illnesses, and will be in the form of self\-care support only)
  • 3\. Patient or their caregiver speaks and reads English adequately to provide informed consent and understand the text prompts in the application
  • 4\. Ability to comply with using the telemonitoring system (e.g, able to stand on the weight scale, able to answer symptom questions, etc)
  • Primary chronic disease\-specific criteria:
  • 1\. Patients with HF as the primary chronic disease: with reduced ejection fraction (EF\<0\.40\)
  • 2\. Patients with COPD as the primary chronic disease: spirometrically confirmed diagnosis of COPD of GOLD Stage II or higher (defined as post\-bronchodilator FEV1 \< 80% predicted and FEV1/FVC ratio \< 70%); smoking history of \= 20 pack\-years or homozygous alpha\-1 antitrypsin deficiency; and prescribed an action plan for the early self\-treatment of acute exacerbations
  • 3\. Patients with CKD as the primary chronic disease: Grade 3\-5 (eGFR \< 60mL/1\.73 m2\)
  • 4\. Patients with uncontrolled hypertension as the primary chronic disease: For non\-diabetics: blood pressure \>\=140/90 mmHg auscultatory (manual measurement) or \>\=135/85 mmHg oscillometric (automated measurement). For diabetics: blood pressure \>\=130/80 mmHg

Exclusion Criteria

  • 1\. Patients on mechanical circulatory support
  • 2\. Patients on the heart transplant list
  • 3\. Terminal diagnosis with life expectancy \< 1 year
  • 4\. Dementia or uncontrolled psychiatric illness
  • 5\. Resident of a long\-term care facility

Outcomes

Primary Outcomes

Not specified

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