CHANGE -it is About Life

NCT01585493 | Completed Phase 3

• 1 other identifier: Change
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. Recently, a large register-based study, involving complete national data from Denmark, Sweden and Finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. Patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.Results from the Danish National Indicator Project for Schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values. In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. We will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the CHANGE team who should facilitate life style changes and contact with general practice. The objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.

Conditions

Schizophrenia; Metabolic Syndrome

Keywords

Lifestyle; Smoking; Dietary; Exercise

Outcome Measures

Primary Outcomes (1)

• Copenhagen Risk Score

  The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.

  12 months

Secondary Outcomes (11)

• Smoking

  12 months

• Sedentary lifestyle

  12

• Body mass index

  12 months

• Blood pressure

  12 months

• Cholesterol

  12 months

Other Outcomes (8)

• Positive and negative symptoms

  12 months

• Cognition

  12 months

• Quality of life

  12 months

Study Arms (3)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual

Other: Treatment as usual

Care coordinator

ACTIVE COMPARATOR

Behavioral: Care coordinator

CHANGE

EXPERIMENTAL

Behavioral: CHANGE

Interventions

Treatment as usual OTHER

Treatment as usual. Patients will be affiliated with local out-patient clinics in secondary mental health services and they will have access to their own general practitioner. No formalized extra effort will be made to ensure treatment of physical disorders.Patients will be affiliated with local out-patient clinics in secondary

Treatment as usual

Care coordinator BEHAVIORAL

Treatment as usual plus a care coordinator (with a caseload of 25 patients) who will facilitate contact to primary care in order to ensure treatment of physical health problems,

Care coordinator

CHANGE BEHAVIORAL

Treatment as usual plus affiliation to a staffmember (caseload 10) from a CHANGE team who will provide individualized, adjusted implementation of widely recognized interventions, such as smoking cessation programmes, motivational interviewing, psychoeducation plus patient involvement in monitoring health statusA multidisciplinary CHANGE team will be established. Team members will be health professionals with experience in smoking cessation programmes or exercise programmes for mentally ill, and experts with competence in dietary issues. CHANGE treatment involve lifestyle coaching, education about diet and physical activity,16 networking and smoking cessation programs. The team members will act as lifestyle coaches for ten patients at a time, map lifestyle and explore and elicit patients' motivation for change.

CHANGE

Eligibility Criteria

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

You may qualify if:

• Affiliated to outpatients services at Mental Health Centre, Copenhagen or Århus University Hospital
• Diagnose ICD-10:F2 spectrum
• Waist circumference \> 88 cm for women or \>102 cm for men

You may not qualify if:

• Not willing to participate

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Mental Health Services in the Capital Region, Denmark

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• Speyer H, Norgaard HC, Hjorthoj C, Madsen TA, Drivsholm S, Pisinger C, Gluud C, Mors O, Krogh J, Nordentoft M. Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity. BMC Psychiatry. 2015 May 23;15:119. doi: 10.1186/s12888-015-0465-2.

  PMID: 26001844 DERIVED

MeSH Terms

Conditions

Schizophrenia; Metabolic Syndrome; Smoking; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Merete Nordentoft, Professor

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 26, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

DK (1)