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

NCT01342263 | Completed

• 1 other identifier: 711174
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Healthcare utilization

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

  24 months

Secondary Outcomes (6)

• health-related Quality of life

  24 months

• Self-management

  24 months

• Social support

  24 months

• Patient and Provider Experience and Satisfaction

  24 months

• Adherence to the iCDM

  24 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

iCDM

EXPERIMENTAL

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.

Behavioral: iCDM

Interventions

iCDM BEHAVIORAL

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.

iCDM

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Fraser University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Michael Smith Foundation for Health Research: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (1)

• 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.

  PMID: 34962560 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Heart Failure; Renal Insufficiency, Chronic; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Scott A Lear, PhD

  Simon Fraser University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 27, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

CA (1)