Lifestyle Intervention For Effective Diabetes Management (LIFE-DM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by St. Michael's Hospital, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
St. Joseph's Health Centre Toronto
University Health Network, Toronto
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00813930
First received: December 22, 2008
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

Chronic disease management programs are shown to reduce mortality, recurrent hospitalizations, and improve indirect societal costs among specific subgroups of the population. INTERxVENT is one such individualized chronic cardiovascular and lifestyle management program, comprised of several individualized modules - diet, exercise, stress management, smoking cessation, chronic disease - prescribed algorithmically according to patient risk profile, environmental surroundings, and behavioural readiness-to-change. Nonrandomized studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome populations have demonstrated improvement in several intermediary endpoints, including reductions in fasting glucose, lipids, and blood pressure. However, no randomized controlled clinical trials in these populations have been conducted. This pilot study is a randomized clinical trial evaluating the effectiveness of INTERxVENT as compared with 'usual medical care' in improving cardiovascular risk-factor profiles among individuals with diabetes. Additionally, the extent to which such findings are generalizable to diabetic, socially vulnerable, populations is unknown, thus this will be examined also.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: INTERxVENT lifestyle modification program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Official Title: Lifestyle Intervention For Effective Diabetes Management (LIFE-DM) Trial

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Six-month United Kingdom Prospective Diabetes Study (UKPDS) risk engine score. The UKPDS risk engine is a validated scoring system that uses multiple clinical characteristics to predict new coronary heart disease risks in patients with type 2 diabetes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Six-month: HbA1c, seated systolic blood pressure, serum Total Cholesterol concentration, serum HDL-C concentration, Total/HDL-C ratio value, LDL-C concentration, self-reported smoking status, adherence to medications and lifestyle measures. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INTERxVENT Program
Participants in INTERxVENT will complete a 'Baseline Assessment' and 'Follow-up' questionnaire, and will have a health professional visit his/her home for an initial assessment (BP,height,weight,waist measurement) and blood collection (blood glucose and cholesterol levels). As part of the program, each participant will also complete a self-reported 'Health History Questionnaire' (HHQ); a follow-up HHQ will be completed about 12 weeks into the program to monitor progress. Each participant randomized to INTERxVENT receives educational articles which address diabetes management issues. A structured, individualized program, consisting of educational materials and 12 live mentoring/coaching telephone calls will take place over 6 months. The mentors consist of allied health professionals. The sequence by which educational content is administered will be both self-directed and guided by the mentors using an algorithmic approach according to the participant's readiness-to-change scores.
Behavioral: INTERxVENT lifestyle modification program
It is a lifestyle behavior modification program which helps Type 2 diabetics manage diabetes better and reduce cardiovascular risk factors. The program involves up to 12 telephone mentor/coaching sessions with a certified health professional.
Other Name: INTERxVENT
No Intervention: Usual medical care
Each participant randomized to this group will not receive any formal intervention but will receive the same care over the 6-month period as he/she usually receives from his/her health care team. Participants in this group will undergo the same baseline and outcome assessment as those in the intervention group, including blood pressure (BP) measurement, physical assessment (height, weight, waist measurement) and blood collection (blood glucose and cholesterol levels), as well as completion of the 'Baseline Assessment' and 'Follow-up' questionnaires.

Detailed Description:

Diabetes is a leading cause of cardiovascular mortality and morbidity, and is more often than not a very difficult disease for individuals to manage effectively. People with diabetes have to be committed to a self-care regimen which includes, careful monitoring of blood sugar, blood pressure, cholesterol, eating healthy, exercising, foot care and regular physical and eye check-ups. This can be quite daunting and stressful for some to undertake themselves, and is largely dependent on individual self-motivation. Family physicians assist their patients in managing their diabetes but they have significant time constraints and may not always be able to deliver the high service intensity required to reduce morbidity and/or may have inadequate access to resources to help patients positively change their self-care behaviour.

Chronic disease-management programs involving home-based nursing health promotion have been shown to reduce mortality, reduce recurrent hospitalization, and improve indirect societal costs among specific subgroups of the population, including those with diabetes, however, such interventions can be costly and cumbersome to implement given the need for home-based visits.

INTERxVENT is a telephone-based, individualized, chronic cardiovascular and lifestyle management program combining a formal management plan, case-managed care (through a coach/mentor), and educational modules to teach patients to modify and sustain healthy lifestyle behaviours. It is comprised of several individualized modules (e.g., diet, exercise, stress management, smoking cessation, chronic disease), which are prescribed algorithmically in accordance to a patient's individual risk profile, environmental surroundings, and behavioural readiness to change. All recommendations are according to best-practice standards and evidence-based guidelines.

Nonrandomized intervention studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome populations have demonstrated significant reductions in biologically relevant measures, such as fasting glucose, glycosylated hemoglobin (HbA1c), lipids, and blood pressure. However, no randomized controlled clinical trials in these populations assessing the impact of INTERxVENT have been conducted.

The proposed pilot study will evaluate the efficacy of INTERxVENT as compared with 'usual medical care' in improving cardiovascular risk-factor profiles among individuals with diabetes. In addition, to what extent a chronic disease management program will yield similar effectiveness in socio-economically disadvantaged individuals is unknown. We hypothesize that chronic disease management programs, like INTERxVENT, will result in improved intermediary biological and behavioural risk profiles for all program participants randomized to this intervention, regardless of socio-economic condition.

The results of this pilot study will determine and assist in designing and ascertaining sample sizes for a larger trial, respectively, should such a trial be warranted. Additionally, such chronic disease management interventions may improve the overall health of partaking individuals and relieve strain and decrease costs within the existing health care system.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes
  • Age 18 years or older

Exclusion Criteria:

  • Documented history of myocardial infarction, stroke, angina, angioplasty, or bypass surgery
  • Unable to understand written and spoken English
  • Presence of cognitive impairment (e.g., dementia) or significant psychological problems (e.g., schizophrenia, schizoaffective disorders) that, in the investigators' opinion, may prohibit the participant from following study protocols
  • Unavailable to participate (e.g., incarceration, no access to a telephone)
  • HIV / AIDS
  • Estimated life expectancy less than one year in the opinion of the clinician
  • Participation in any other clinical study
  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: NCT00813930

Locations
Canada, Ontario
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
St. Joseph's Health Centre Toronto
University Health Network, Toronto
Investigators
Principal Investigator: Gillian L. Booth, MD, MSc Li Ka Shing Knowledge Institute, St. Michael's Hospital
  More Information

Publications:
Shah BR, Mamdani M, Kopp A: Drug Use in Older People with Diabetes. In Diabetes in Ontario: an ICES practice atlas. Hux JE, Booth GL, Slaughter P, Laupacis A, Eds. Toronto, Insitute for Clinical Evaluative Sciences, 2003.

Responsible Party: Dr. Gillian Booth, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00813930     History of Changes
Other Study ID Numbers: SMH-LKSKI
Study First Received: December 22, 2008
Last Updated: March 22, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Diabetes
Lifestyle Intervention
Cardiovascular risk reduction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014