Trial of an Internet-based Platform for Managing Chronic Diseases at a Distance (iCDM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Simon Fraser University
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Michael Smith Foundation for Health Research
Information provided by (Responsible Party):
Scott Lear, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01342263
First received: April 21, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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?


Condition Intervention
Ischemic Heart Disease
Heart Failure
Chronic Kidney Disease
Diabetes
Chronic Obstructive Pulmonary Disease
Behavioral: iCDM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utilization of an Interactive Internet-based Platform for Managing Chronic Diseases at a Distance

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • Healthcare utilization [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Hospital admissions, length of hospital stay, emergency room visits, physician visits, diagnostic and lab procedures.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed by the Medical Outcomes Study 36-item Short Form survey.

  • Self-management [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed by the Health Education Impact Questionnaire (heiQ).

  • Social support [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed using the Medical Outcomes Study Social Support Scale.

  • Patient and Provider Experience and Satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients enrolled in the iCDM intervention and their family physicians will undergo a semi-structured, open-ended interview at the end of the intervention to explore patient experiences and to increase our understanding of patient factors that influence acceptance and use.

  • Adherence to the iCDM [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed through website use (logins) and completion of data entry.

  • Health outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessed by the EuroQol EQ-5D-5L health questionnaire.


Estimated Enrollment: 318
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Does not get to participate in the interactive chronic disease website.
Experimental: iCDM
The iCDM intervention will be managed by a nurse with experience in chronic disease management who will review patient data, communicate with the patients, implement the Treatment Algorithms and interact with the patients' PCP. Patients will also be able to interact with a dietitian and exercise specialist to support them in their disease management.
Behavioral: iCDM
The iCDM intervention will be managed by a nurse with experience in chronic disease management who will review patient data, communicate with the patients, implement the Treatment Algorithms and interact with the patients' PCP. Patients will also be able to interact with a dietitian and exercise specialist to support them in their disease management. These personnel will have formal training in principles of the Transtheoretical Model of Change and Social Cognitive Theory.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • two or more of the following chronic diseases; heart disease, heart failure, chronic kidney disease, diabetes and COPD
  • daily Internet access
  • able to read, write and understand English

Exclusion Criteria:

  • patients with significant co-morbidities that may interfere with effective management
  • patients who have scheduled surgical procedures
  • patients who are unable to provide informed consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342263

Contacts
Contact: Scott A Lear, PhD 778-782-7916 slear@providencehealth.bc.ca

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Scott A Lear, PhD    604-682-2344 ext 62778    slear@providencehealth.bc.ca   
Principal Investigator: Scott A Lear, PhD         
Sponsors and Collaborators
Simon Fraser University
Canadian Institutes of Health Research (CIHR)
Michael Smith Foundation for Health Research
Investigators
Principal Investigator: Scott A Lear, PhD Simon Fraser University
  More Information

No publications provided

Responsible Party: Scott Lear, Professor, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01342263     History of Changes
Other Study ID Numbers: 711174
Study First Received: April 21, 2011
Last Updated: August 26, 2013
Health Authority: Canada: Simon Fraser University
Canada: Northern Health Authority
Canada: Fraser Health Authority
Canada: Providence Health Care
Canada: Interior Health Authority
Canada: Vancouver Coastal Health Authority

Keywords provided by Simon Fraser University:
Chronic disease management
Ischemic heart disease
Heart failure
Chronic kidney disease
Diabetes
Chronic obstructive pulmonary disease
Telehealth
Internet

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Heart Diseases
Pulmonary Disease, Chronic Obstructive
Kidney Diseases
Renal Insufficiency, Chronic
Chronic Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014