Heart DiseasesNCT00738231
Training Methods for a Doctrine Of Life With Healthy Heart
A study testing Training in people with Heart Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study is an interventional study which was conducted in the field. The investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2007to Dec 2009
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 40 years of age were contacted.
- Individuals who were literate or had at least one literate person in the household were selected through random sampling via the records of local health care units.
Who cannot join
- Under 40 years of age and immigrants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Distinct Training Methods for Healthy Heart in Low Social and Economical Society
This study is an interventional study which was conducted in the field. The investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and cheap methods to decrease risk factors.
In this study, the aim of preparing the Group II training material was to enable the individual to see his or her risks as unique, and to proceed with life by adapting personal behaviors. Group II's training material was formatted as a prescription. Because giving a prescription for a doctor is very important in low socioeconomical group person.
This study showed that social programs oriented towards individual behavioral changes assume an important role in decreasing cardiovascular risk factors.
Read the detailed description
Background:
Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and economical methods to decrease risk factors.
Methods:
This study was conducted in three stages in a semi-rural region of Eskisehir, Turkey. In the first stage, individuals selected by random sampling were evaluated in terms of social-demographic characteristics and the risk factors present for cardiovascular diseases. A scale comprised of 19 questions was implemented for data assessment. In the second stage, training materials were randomly distributed. Group I's training material consisted of a brochure containing pictures and general information on heart disease; Group II members additionally received a personalized letter that further explained their individual risk factors and suggested measures for increased protection and prevention - in short, Group II's training material was formatted as a prescription. In the third stage, the subjects were screen against the cardiovascular risks factors one year later to assess and determine if there had been any changes in their attitudes towards the dangers of the cardiovascular diseases.
- Conditions
- Heart Diseases
- Being tested
- Training
- Keywords
- risk factors; coronary arterial hearth disease
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Also called CAHD; TM
The training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
TrainingBehavioural
Also called CAHD; TM
The training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Group I's training material consisted of a brochure with the information we wanted the public to know about heart disease. The brochure had such titles as "Cardiovascular Diseases, let us protect our hearts, the importance of cholesterol in preventing heart diseases, watch out for blood pressure, quit smoking for your health, weight watching, nutrition, food to avoid in cardiovascular disease, an easy method: exercise and exercise control, and an appropriate body weight vs. height chart for adults" Receives: Behavioral: Training |
| II | Active comparator | The Group II training material document was a letter in the form of a prescription in which the individual was addressed by name, the risk factors established at the first stage were explained, and the suggested measures for protection from such risk factors were indicated. Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of score of the knowledge about the risk factors for cardiovascular diseases
Measured: 1 month
Secondary outcomes (1)
Stop smoking; to regulate of arterial tension; properly change of feeding behaviour
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Investigators
- Selma Metintas, MD,Prof., Study chair, ESOGU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738231
- Sponsor's protocol ID
- 2007/37
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Distinct Training Methods for Healthy Heart in Low Social and Economical Society
- ClinicalTrials.gov ID
- NCT00738231
- Acronym / sponsor ID
- 2007/37
- Conditions
- Heart Diseases
- Keywords
- risk factors; coronary arterial hearth disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 Aug 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 an interventional study which was conducted in the field. The investigators intended to develop an efficient and economically valuable method which can decrease the risk factors for prevention of cardiovascular diseases. Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and cheap methods to decrease risk factors.
In this study, the aim of preparing the Group II training material was to enable the individual to see his or her risks as unique, and to proceed with life by adapting personal behaviors. Group II's training material was formatted as a prescription. Because giving a prescription for a doctor is very important in low socioeconomical group person.
This study showed that social programs oriented towards individual behavioral changes assume an important role in decreasing cardiovascular risk factors.
Detailed description
Background:
Effective control of cardiovascular diseases necessitates a salutogenetic approach to develop efficient and economical methods to decrease risk factors.
Methods:
This study was conducted in three stages in a semi-rural region of Eskisehir, Turkey. In the first stage, individuals selected by random sampling were evaluated in terms of social-demographic characteristics and the risk factors present for cardiovascular diseases. A scale comprised of 19 questions was implemented for data assessment. In the second stage, training materials were randomly distributed. Group I's training material consisted of a brochure containing pictures and general information on heart disease; Group II members additionally received a personalized letter that further explained their individual risk factors and suggested measures for increased protection and prevention - in short, Group II's training material was formatted as a prescription. In the third stage, the subjects were screen against the cardiovascular risks factors one year later to assess and determine if there had been any changes in their attitudes towards the dangers of the cardiovascular diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Behavioral: TrainingGroup I's training material consisted of a brochure with the information we wanted the public to know about heart disease. The brochure had such titles as "Cardiovascular Diseases, let us protect our hearts, the importance of cholesterol in preventing heart diseases, watch out for blood pressure, quit smoking for your health, weight watching, nutrition, food to avoid in cardiovascular disease, an easy method: exercise and exercise control, and an appropriate body weight vs. height chart for adults" |
| II | Active comparator | Behavioral: TrainingThe Group II training material document was a letter in the form of a prescription in which the individual was addressed by name, the risk factors established at the first stage were explained, and the suggested measures for protection from such risk factors were indicated. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 40 years of age were contacted.
- Individuals who were literate or had at least one literate person in the household were selected through random sampling via the records of local health care units.
Key exclusion criteria (1 listed)
- Under 40 years of age and immigrants
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 |
|---|---|---|
| TrainingAlso: CAHD; TMThe training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure. | Behavioural | I |
| TrainingAlso: CAHD; TMThe training materials were randomly distributed to study participant groups. The list of names was systematically divided into two groups: odd-numbered individuals were given brochures only, and even-numbered individuals were given both letters and brochures. Since we could not have prevented an illustrated material to be passed by in a closed environment, it was deemed appropriate to distribute both the letter and brochure instead of just the brochure. | Behavioural | II |
Primary outcome
Increase of score of the knowledge about the risk factors for cardiovascular diseases
Time frame: 1 month
1 secondary outcome
Stop smoking; to regulate of arterial tension; properly change of feeding behaviour
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
- Eskisehir Osmangazi UniversityLink provided by the sponsor.
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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.
Selma Metintas, MD,Prof. study chair
ESOGU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Heart Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 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: status not confirmed, as of the sponsor's last update on 19 Jun 2009. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
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?
Increase of score of the knowledge about the risk factors for cardiovascular diseases (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2009.