Lifestyle Intervention For Effective Diabetes Management

Diabetes Mellitus, Type 2 Clinical Trial

— LIFE-DM  

Official title:

Lifestyle Intervention For Effective Diabetes Management (LIFE-DM) Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00813930
• Other study ID #: SMH-LKSKI
• Status: Active, not recruiting
• Phase: N/A
• First received: December 22, 2008
• Last updated: March 22, 2010
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2010
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	University Health Network, Toronto Western Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	St. Joseph's Health Centre Toronto, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Bonow RO, Gheorghiade M. The diabetes epidemic: a national and global crisis. Am J Med. 2004 Mar 8;116 Suppl 5A:2S-10S. Review. — View Citation

Booth GL, Kapral MK, Fung K, Tu JV. Recent trends in cardiovascular complications among men and women with and without diabetes. Diabetes Care. 2006 Jan;29(1):32-7. — View Citation

Booth GL, Kapral MK, Fung K, Tu JV. Relation between age and cardiovascular disease in men and women with diabetes compared with non-diabetic people: a population-based retrospective cohort study. Lancet. 2006 Jul 1;368(9529):29-36. — View Citation

Buhrmann R, Asaad D, Hux JE, Tang M, Sykora K: Diabetes and the Eye. In Diabetes in Ontario: an ICES practice atlas. Hux JE, Booth GL, Slaughter P, Laupacis A, Eds. Toronto, Institute for Clinical Evaluative Sciences, 2003.

Gordon NF, English CD, Contractor AS, Salmon RD, Leighton RF, Franklin BA, Haskell WL. Effectiveness of three models for comprehensive cardiovascular disease risk reduction. Am J Cardiol. 2002 Jun 1;89(11):1263-8. — View Citation

Gordon NF, Salmon RD, Franklin BA, Sperling LS, Hall L, Leighton RF, Haskell WL. Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia. Am J Cardiol. 2004 Dec 15;94(12):1558-61. — View Citation

Gordon NF, Salmon RD, Mitchell BS, Faircloth GC, Levinrad LI, Salmon S, Saxon WE, Reid KS. Innovative approaches to comprehensive cardiovascular disease risk reduction in clinical and community-based settings. Curr Atheroscler Rep. 2001 Nov;3(6):498-506. Review. — View Citation

Markle-Reid M, Browne G, Weir R, Gafni A, Roberts J, Henderson SR. The effectiveness and efficiency of home-based nursing health promotion for older people: a review of the literature. Med Care Res Rev. 2006 Oct;63(5):531-69. Review. — View Citation

Markle-Reid M, Weir R, Browne G, Roberts J, Gafni A, Henderson S. Health promotion for frail older home care clients. J Adv Nurs. 2006 May;54(3):381-95. — View Citation

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.

Simpson SH, Corabian P, Jacobs P, Johnson JA. The cost of major comorbidity in people with diabetes mellitus. CMAJ. 2003 Jun 24;168(13):1661-7. — View Citation

Stevens RJ, Kothari V, Adler AI, Stratton IM; United Kingdom Prospective Diabetes Study (UKPDS) Group. The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56). Clin Sci (Lond). 2001 Dec;101(6):671-9. Erratum in: Clin Sci (Lond) 2002 Jun;102(6):679. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Secondary	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.		6 months	No