Heart Failure Clinical Trial
Official title:
Utilization of an Interactive Internet-based Platform for Managing Chronic Diseases at a Distance
In 2005, more then one-third of Canadians were burdened with one or more chronic diseases.
Patients with one chronic disease often have, or are at risk for, another chronic disease.
This group of complex patients represents a substantial challenge to healthcare resources.
For patients in rural communities, the opportunity to attend ambulatory care clinics is not
always an option. Additionally, the opportunity for rural patients to receive quality care
close to, or within their homes, is of great benefit as it reduces the need for extensive
travel and the potential burden of clinical visits. The use of telehealth has been identified
as an effective modality for chronic disease management and is actively promoted by national
organizations as having great promise for health service delivery in rural areas. The
Internet as a mode for healthcare delivery has numerous advantages: 1. it is ubiquitous with
increasing access in all age groups, 2. it is inexpensive, 3. it facilitates both patient
data transfer and patient feedback, thereby supporting patient self-management, 4. it is
scalable to large patient volumes, 5. it delivers health care directly to the patient and 6.
it requires minimal set-up for patients with current Internet access.
The investigators propose to develop and evaluate a multi-chronic disease management program
delivered through the Internet (with telephone supports) focused on high-impact chronic
diseases targeted to patients in rural communities.
This study will consist of a single-blinded randomized controlled trial to investigate the
efficacy of the iCDM in 318 patients with two or more of the target chronic diseases living
in rural areas. Within this Aim, the investigators will be able to address the following
research questions:
Q1. What is the effect of iCDM on healthcare utilization and patient self-management
outcomes? Q2. What is the long-term compliance to the iCDM? Q3. What is the level of patient
and provider satisfaction?
A study population of men and women over 19 years will be identified through nurse
practitioners, primary care networks, and other practicing primary care physicians located
within the Northern Health, Fraser Health, Interior Health, Vancouver Island Health and
Vancouver Coastal Health Authorities. Patients will be eligible if they have two or more of
the five targeted chronic diseases; daily Internet access (home, work or other environment)
by and means; and able to read, write and understand English without difficulty. A total of
318 patients (159 per group) will be recruited and randomized to either usual care, or a
24-month interactive chronic disease management program delivered via the Internet.
Usual Care Group Patients randomized to usual care will be given educational information
regarding general chronic disease management and a list of Internet-based resources, and will
return to the care of their primary care physician. Patients will be contacted after 24
months for an outcome assessment. There will be no contact between the study personnel and
usual care patients for the duration of the study, nor will there be any attempt to control
the level of patient care.
iCDM Experimental Group The iCDM is a 24-month interactive website that has been designed for
patients with two or more of the following chronic diseases: ischemic heart disease, heart
failure, diabetes, chronic kidney disease and chronic obstructive pulmonary disease. The iCDM
is managed by a nurse with experience in chronic disease management who will review patient
data, communicate with patients, implement treatment and interact with the patients' primary
care physician. Patients will also be able to interact with a dietician and exercise
specialist to support their disease management.
The main premise of the iCDM is that users will log-on on a regular basis and enter data
related to how they are feeling and some physical measures (such as body weight, blood sugar,
blood pressure, as relevant). Based on answers to these questions, the website may show a
message either saying everything is fine or give a warning, informing the patient of their
answers and that a nurse will be contacting them on the next business day. If the nurse
receives an alert in his/her email inbox, he/she will telephone the patient within
approximately 24 hours to discuss the entered data. The nurse may also direct the patient to
discuss with the dietician or exercise specialist, or tell them that it is probably best for
them to visit their physician for their symptoms.
Patients will have access to the iCDM for a 24 month period. Their family physician will
receive a letter indicating their participation in the program and the conditions under which
they may be contacted. At 24 months patients will be contacted for an outcome assessment.
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