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

Primary Purpose

Ischemic Heart Disease, Heart Failure, Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iCDM
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Chronic disease management, Ischemic heart disease, Heart failure, Chronic kidney disease, Diabetes, Chronic obstructive pulmonary disease, Telehealth, Internet

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

iCDM

Arm Description

Does not get to participate in the interactive chronic disease website.

The iCDM will support patient self-management through collaborative planning and goal setting, education and skill development, support for behaviour change, and regular patient monitoring with follow-up. For each chronic condition, we have outlined sample patient signs and symptoms to be monitored, frequency of patient provider contact and frequency of patient prompt questions on their condition. The main premise of the iCDM is that only those patients who generate 'alerts' will be contacted by the iCDM nurse allowing for the potential to manage more patients than through traditional means of required patient follow-up regardless of patient condition . Across these five diseases are the following cross-cutting features: nutrition therapy, exercise therapy, psychological support, medication adherence and smoking cessation.

Outcomes

Primary Outcome Measures

Healthcare utilization
Hospital admissions, length of hospital stay, emergency room visits, physician visits, diagnostic and lab procedures.

Secondary Outcome Measures

health-related Quality of life
Assessed by the Medical Outcomes Study 36-item Short Form survey.
Self-management
Assessed by the Health Education Impact Questionnaire (heiQ).
Social support
Assessed using the Medical Outcomes Study Social Support Scale.
Patient and Provider Experience and Satisfaction
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
Assessed through website use (logins) and completion of data entry.
Health outcomes
Assessed by the EuroQol EQ-5D-5L health questionnaire.

Full Information

First Posted
April 21, 2011
Last Updated
September 7, 2018
Sponsor
Simon Fraser University
Collaborators
Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT01342263
Brief Title
Trial of an Internet-based Platform for Managing Chronic Diseases at a Distance
Acronym
iCDM
Official Title
Utilization of an Interactive Internet-based Platform for Managing Chronic Diseases at a Distance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Heart Failure, Chronic Kidney Disease, Diabetes, Chronic Obstructive Pulmonary Disease
Keywords
Chronic disease management, Ischemic heart disease, Heart failure, Chronic kidney disease, Diabetes, Chronic obstructive pulmonary disease, Telehealth, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Does not get to participate in the interactive chronic disease website.
Arm Title
iCDM
Arm Type
Experimental
Arm Description
The iCDM will support patient self-management through collaborative planning and goal setting, education and skill development, support for behaviour change, and regular patient monitoring with follow-up. For each chronic condition, we have outlined sample patient signs and symptoms to be monitored, frequency of patient provider contact and frequency of patient prompt questions on their condition. The main premise of the iCDM is that only those patients who generate 'alerts' will be contacted by the iCDM nurse allowing for the potential to manage more patients than through traditional means of required patient follow-up regardless of patient condition . Across these five diseases are the following cross-cutting features: nutrition therapy, exercise therapy, psychological support, medication adherence and smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
iCDM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healthcare utilization
Description
Hospital admissions, length of hospital stay, emergency room visits, physician visits, diagnostic and lab procedures.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
health-related Quality of life
Description
Assessed by the Medical Outcomes Study 36-item Short Form survey.
Time Frame
24 months
Title
Self-management
Description
Assessed by the Health Education Impact Questionnaire (heiQ).
Time Frame
24 months
Title
Social support
Description
Assessed using the Medical Outcomes Study Social Support Scale.
Time Frame
24 months
Title
Patient and Provider Experience and Satisfaction
Description
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.
Time Frame
24 months
Title
Adherence to the iCDM
Description
Assessed through website use (logins) and completion of data entry.
Time Frame
24 months
Title
Health outcomes
Description
Assessed by the EuroQol EQ-5D-5L health questionnaire.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Lear, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34962560
Citation
Lear SA, Norena M, Banner D, Whitehurst DGT, Gill S, Burns J, Kandola DK, Johnston S, Horvat D, Vincent K, Levin A, Kaan A, Van Spall HGC, Singer J. Assessment of an Interactive Digital Health-Based Self-management Program to Reduce Hospitalizations Among Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2140591. doi: 10.1001/jamanetworkopen.2021.40591.
Results Reference
derived

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

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