SchizophreniaPhase 3NCT01585493
CHANGE -it is About Life
A Phase 3 study testing Treatment as usual, Care coordinator and CHANGE in people with Schizophrenia and Metabolic Syndrome, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome
- What is being tested?
- Treatment as usual, Care coordinator and CHANGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mental Health Services in the Capital Region, Denmark
Copenhagen, 2400
About this study
Official title: CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
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
- Being tested
- Treatment as usual, Care coordinator, CHANGE
- Keywords
- Lifestyle, Smoking, Dietary, Exercise
- Medical subject headings
- Schizophrenia, Metabolic Syndrome, Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualOther
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
Care coordinatorBehavioural
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,
CHANGEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Treatment as usual Receives: Other: Treatment as usual |
| Care coordinator | Active comparator | Not described Receives: Behavioral: Care coordinator |
| CHANGE | Experimental | Not described Receives: Behavioral: CHANGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copenhagen Risk Score
The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.
Measured: 12 months
Secondary outcomes (11)
Smoking
Number of daily smokers in each group at 12 months
Measured: 12 months
Sedentary lifestyle
Self reported hours of sedentary behavior
Measured: 12
Body mass index
Change in body mass index at 12 months
Measured: 12 months
Blood pressure
Change in systolic and diastolic blood pressure at 12 months
Measured: 12 months
Cholesterol
Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months
Measured: 12 months
Aerobic fitness
Indirectly estimated maximal oxygen uptake
Measured: 12 months
Waist circumference
Measured between crista iliaca and the lowest rib
Measured: 12 months
Forced expiratory volume
Measured: 12 months
Resting heart rate
Measured: 12 months
HbA1c
Measured: 12 months
Physical activity
Change in minutes of MVPA a week
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Merete Nordentoft, Professor, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585493
- Sponsor's protocol ID
- Change
- Status last verified
- Oct 2016
- First submitted
- 27 Mar 2012
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26001844
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01585493
- Acronym / sponsor ID
- Change
- Conditions
- Schizophrenia, Metabolic Syndrome
- Keywords
- Lifestyle, Smoking, Dietary, Exercise
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Dec 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Treatment as usualTreatment as usual |
| Care coordinator | Active comparator | Behavioral: Care coordinator |
| CHANGE | Experimental | Behavioral: CHANGE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualTreatment 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 | Other | Treatment as usual |
| Care coordinatorTreatment 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, | Behavioural | Care coordinator |
| CHANGETreatment 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. | Behavioural | CHANGE |
Primary outcome
Copenhagen Risk Score
Time frame: 12 months
The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.
11 secondary outcomes
Smoking
Time frame: 12 months
Sedentary lifestyle
Time frame: 12
Body mass index
Time frame: 12 months
Blood pressure
Time frame: 12 months
Cholesterol
Time frame: 12 months
Aerobic fitness
Time frame: 12 months
Waist circumference
Time frame: 12 months
Forced expiratory volume
Time frame: 12 months
Resting heart rate
Time frame: 12 months
HbA1c
Time frame: 12 months
Physical activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 26001844Speyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, Professor principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment as usual, Care coordinator and CHANGE in people with Schizophrenia and Metabolic Syndrome, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copenhagen Risk Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016; AzTrials last refreshed its copy on 5 Nov 2026.