Drug or Chemical Induced Diabetes MellitusNCT01964612
Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model
An observational study of Drug or Chemical Induced Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Drug or Chemical Induced Diabetes Mellitus
- How many people
- 460 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Dec 2016
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with obvious chronic diseases of hypertension or diabetes, or both diseases diagnosed by doctors in Taiwan.
Who may be able to join
- adults aged 20 and above, with hypertension or diabetes or both diseases.
Who cannot join
- adults with other severe physical diseases.
- adults with relevant psychological diseases.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hopital
Taipei, Taiwan, 100
Bee-Horng Lue, MD, 886-2-23123456, grace@ntu.edu.tw
About this study
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.
Read the detailed description
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. They need adjust themselves and their crisis lives, and some plan they had made the near or distant future. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.Research methods will separate three year project to describe. First year project will use qualitative methods from bio-psychosocial aspects to interview participants who may suffer illness after diagnosis or stable treatment during middle phase of illness. Second year will invite diabetes and hypertension patients from different phase of illness with different levels of health anxiety trait, meta-cognitive and control strategies if derived different coping and emotions outcome. The third year will design motivational psycho-education program for patients to alleviate the emotions and use cold meta-cognition to due good health behavior and self care with their illness. The expected results will like to test the investigators new model in caring chronic disease patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
self-monitoring and self-control scale
Measured: one year
Secondary outcomes (5)
meta-thinking awareness scale
Measured: one year
negative self thinking scale
Measured: one year
depression and anxiety scale
Measured: one year
life change scale
Measured: one year
health anxiety scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug or Chemical Induced Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bee-Horng Lue, MD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964612
- Sponsor's protocol ID
- 201205106RIC
- Status last verified
- Oct 2013
- First submitted
- 8 Oct 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model
- ClinicalTrials.gov ID
- NCT01964612
- Acronym / sponsor ID
- 201205106RIC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2016 (estimated)
- First posted
- 17 Oct 2013 (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.
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.
Detailed description
Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. They need adjust themselves and their crisis lives, and some plan they had made the near or distant future. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.Research methods will separate three year project to describe. First year project will use qualitative methods from bio-psychosocial aspects to interview participants who may suffer illness after diagnosis or stable treatment during middle phase of illness. Second year will invite diabetes and hypertension patients from different phase of illness with different levels of health anxiety trait, meta-cognitive and control strategies if derived different coping and emotions outcome. The third year will design motivational psycho-education program for patients to alleviate the emotions and use cold meta-cognition to due good health behavior and self care with their illness. The expected results will like to test the investigators new model in caring chronic disease patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with obvious chronic diseases of hypertension or diabetes, or both diseases diagnosed by doctors in Taiwan.
Key inclusion criteria (1 listed)
- adults aged 20 and above, with hypertension or diabetes or both diseases.
Key exclusion criteria (2 listed)
- adults with other severe physical diseases.
- adults with relevant psychological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
self-monitoring and self-control scale
Time frame: one year
5 secondary outcomes
meta-thinking awareness scale
Time frame: one year
negative self thinking scale
Time frame: one year
depression and anxiety scale
Time frame: one year
life change scale
Time frame: one year
health anxiety scale
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2013.
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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.
Bee-Horng Lue, MD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug or Chemical Induced Diabetes Mellitus, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2013. 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 Taiwan. 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?
Contact Bee-Horng Lue, MD (886-2-23123456, grace@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-monitoring and self-control scale (time frame: one year). 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 17 Oct 2013.