DyslipidemiaPhase 4DISSEMINATENCT00708370
A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.
A Phase 4 study testing COACH in people with Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Malaysia.
Trial summary
This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- COACH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 22 sitesMalaysia
- Study dates
- Aug 2008to Jun 2010
- Phase
- Phase 4
- 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
- Subjects who are newly diagnosed with dyslipidemias.
- Subjects must be lipid drug naive and eligible for statin therapy.
Who cannot join
- Subjects who cannot be contacted by telephone or handphone.
- Subjects with uncontrolled primary hypothyroidism.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Malaysia22 sites
Pfizer Investigational Site
Bagan Serai, Perak, 34300
Pfizer Investigational Site
Cheras, Kuala Lumpur, 55300
Pfizer Investigational Site
Cheras, Kuala Lumpur, 56000
Pfizer Investigational Site
Jitra, Kubang Pasu, Kedah, 06200
Pfizer Investigational Site
Kampong Kemaman, Terengganu, 24100
Pfizer Investigational Site
Kampung Baharu Nilai, Negeri Sembilan, 71800
Pfizer Investigational Site
Kapar, Selangor, 42200
Pfizer Investigational Site
Kerteh, Kemaman, Terengganu, 24300
Pfizer Investigational Site
Kuala Lumpur, Kuala Lumpur, 57000
Pfizer Investigational Site
Kuala Lumpur, 50480
Pfizer Investigational Site
Kuala Lumpur, 52000
Pfizer Investigational Site
Kubang Kerian, Kelantan, 16150
Pfizer Investigational Site
Kulim, Kedah, 09400
Pfizer Investigational Site
Lenggong, Perak, 33400
Pfizer Investigational Site
Malacca, 75460
Pfizer Investigational Site
Petaling Jaya, Selangor, 46000
Pfizer Investigational Site
Puchong, Selangor, 47100
Pfizer Investigational Site
Shah Alam, 40460
Pfizer Investigational Site
Sik, Kedah, 08200
Pfizer Investigational Site
Slim River, Perak, 35860
Pfizer Investigational Site
Sungai Buloh, Selangor, 47000
Pfizer Investigational Site
Tampin, Negeri Sembilan, 73000
About this study
Official title: An Outcome Research on the Impact of a Disease Management Program (COACH) on the Attainment of Better Cardiovascular Risk Control in Dyslipidemic Patients at Primary Care Centers (DISSEMINATE).
This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients.
Read the detailed description
Educational / Counseling
- Conditions
- Dyslipidemia
- Being tested
- COACH, No intervention for placebo
- Keywords
- Interventional, Non-drug, Disease Management Program, Cardiovascular Risk Control, Dyslipidemias, Primary Care Centers
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COACHOther
Also called COACH plus Standard Care
COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.
No intervention for placeboOther
Also called Placebo
There will be no COACH health tele-counselling to patients randomized to Standard Care arm.
| Study group | Role | What they receive |
|---|---|---|
| COACH | Active comparator | Not described Receives: Other: COACH |
| Standard Care | Placebo comparator | Not described Receives: Other: No intervention for placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) change from baseline to week 24 in serum LDL-C levels.
Measured: 24 weeks from Baseline
Secondary outcomes (5)
Subjects' lifestyle modification as assessed by the incidence and frequency of smoking, consumption of foods high in salt, sugar and/or fat content, alcohol consumption, and exercise habits at baseline and weeks 24 and 36.
Measured: 24 and 36 weeks from Baseline
Percentage (%) change from baseline in serum LDL-C (week 36), TC (week 24 and 36), HDL-C (week 24 and 36), TG (week 24 and 36) and TC/HDL-C ratio (week 24 and 36).
Measured: 24 and 36 weeks from Baseline
Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.
Measured: 24 weeks from Baseline
Absolute change in SBP and DBP from baseline to weeks 24 and 36.
Measured: 24 and 36 weeks from Baseline
Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.
Measured: 24 and 36 weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionJun 2010
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 DyslipidemiaStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708370
- Sponsor's protocol ID
- A2581162
- Acronym
- DISSEMINATE
- Status last verified
- Feb 2021
- First submitted
- 27 Jun 2008
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Selvaraj FJ, Mohamed M, Omar K, Nanthan S, Kusiar Z, Subramaniam SY, Ali N, Karanakaran K, Ahmad F, Low WH; DISSEMINATE study group. The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial. BMC Fam Pract. 2012 Oct 10;13:97. doi: 10.1186/1471-2296-13-97.
PubMed 23046818
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outcome Research on the Impact of a Disease Management Program (COACH) on the Attainment of Better Cardiovascular Risk Control in Dyslipidemic Patients at Primary Care Centers (DISSEMINATE).
- ClinicalTrials.gov ID
- NCT00708370
- Acronym / sponsor ID
- DISSEMINATE / A2581162
- Conditions
- Dyslipidemia
- Keywords
- Interventional, Non-drug, Disease Management Program, Cardiovascular Risk Control, Dyslipidemias, Primary Care Centers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Jul 2008 (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.
This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients.
Detailed description
Educational / Counseling
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COACH | Active comparator | Other: COACH |
| Standard Care | Placebo comparator | Other: No intervention for placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who are newly diagnosed with dyslipidemias.
- Subjects must be lipid drug naive and eligible for statin therapy.
Key exclusion criteria (2 listed)
- Subjects who cannot be contacted by telephone or handphone.
- Subjects with uncontrolled primary hypothyroidism.
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 |
|---|---|---|
| COACHAlso: COACH plus Standard CareCOACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks. | Other | COACH |
| No intervention for placeboAlso: PlaceboThere will be no COACH health tele-counselling to patients randomized to Standard Care arm. | Other | Standard Care |
Primary outcome
Percentage (%) change from baseline to week 24 in serum LDL-C levels.
Time frame: 24 weeks from Baseline
5 secondary outcomes
Subjects' lifestyle modification as assessed by the incidence and frequency of smoking, consumption of foods high in salt, sugar and/or fat content, alcohol consumption, and exercise habits at baseline and weeks 24 and 36.
Time frame: 24 and 36 weeks from Baseline
Percentage (%) change from baseline in serum LDL-C (week 36), TC (week 24 and 36), HDL-C (week 24 and 36), TG (week 24 and 36) and TC/HDL-C ratio (week 24 and 36).
Time frame: 24 and 36 weeks from Baseline
Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.
Time frame: 24 weeks from Baseline
Absolute change in SBP and DBP from baseline to weeks 24 and 36.
Time frame: 24 and 36 weeks from Baseline
Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.
Time frame: 24 and 36 weeks from Baseline
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 18 Feb 2021.
- Derived from this study: PubMed 23046818Selvaraj FJ, Mohamed M, Omar K, Nanthan S, Kusiar Z, Subramaniam SY, Ali N, Karanakaran K, Ahmad F, Low WH; DISSEMINATE study group. The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial. BMC Fam Pract. 2012 Oct 10;13:97. doi: 10.1186/1471-2296-13-97.
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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.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COACH in people with Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Malaysia.
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 2 inclusion and 2 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Malaysia. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage (%) change from baseline to week 24 in serum LDL-C levels. (time frame: 24 weeks from Baseline). 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 NCT00708370, 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 18 Feb 2021.