Impact of Structured DTTP on Quality of LifeNCT00444483
Structured Patient Education and Quality of Life of Elderly Patients With Diabetes Mellitus- a Prospective Study
A study testing Structured diabetes teaching and treatment program in people with Impact of Structured DTTP on Quality of Life and Insulin Therapy, run by Heidelberg University.
Trial summary
The improvement of the quality of life (QoL) is one of the key treatment goals in patients with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 54 years and older
- Conditions the study is for
- Impact of Structured DTTP on Quality of Life, Insulin Therapy, Metabolic Control
- What is being tested?
- Structured diabetes teaching and treatment program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 54 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- diabetes mellitus, insulin therapy, age >54 years, hyperglycemia
Who cannot join
- dementia, severe neurological deficits, polioencephalitis, rejection of informed consent
About this study
Official title: Structured Treatment and Teaching of Elderly Patients With Type 2 Diabetes Mellitus
The improvement of the quality of life (QoL) is one of the key treatment goals in patients with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes mellitus. Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic therapy were successively recruited and participated in the structured inpatient diabetes treatment and teaching program (DTTP) for insulin therapy QoL was assessed before and six months after participation in the DTTP with the standardised questionnaire of Lohr analysing the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles.
Read the detailed description
All patients with type 2 diabetes mellitus, who were older than 54 years and admitted by general practitioner to the inpatient unit of the university hospital of Jena, Germany, for participation in a structured DTTP for insulin therapy because of hyperglycemia, were candidates for successive inclusion in the study. All patients participated in a five day inpatient structured DTTP for single or split dose administration of intermediate-acting insulin which included instruction in insulin injection, self- monitoring, hypoglycemia, acute/late complications, nutrition and foot care. Quality of life was assessed by using a validated instrument, the standardised QoL- questionnaire of Lohr et al. (21) both before and six months after participation in the DTTP. This questionnaire consists of 58 Likert- scaled items comprising the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles. Higher scores reflect higher quality of life with 100% as an optimum quality of life. The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.
- Conditions
- Impact of Structured DTTP on Quality of Life, Insulin Therapy, Metabolic Control, Psychological Aspects
- Being tested
- Structured diabetes teaching and treatment program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured diabetes teaching and treatment programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.
Secondary outcomes (1)
A secondary objective of the study was the comparison of QoL- subscale in patients already on insulin therapy with those newly on insulin therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Structured DTTP on Quality of LifeStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Investigators
- Ulrich Müller, MD, Principal investigator, University of JenaAnke Braun, MD, Study chair, Bethanien Hospital Heidelberg, GermanyRalf Schiel, MD, Study chair, Inselklinik Heringsdorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444483
- Sponsor's protocol ID
- 0099-9/98 (KIMII)-955
- Status last verified
- Mar 2007
- First submitted
- 6 Mar 2007
- Last updated
- 7 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Treatment and Teaching of Elderly Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00444483
- Acronym / sponsor ID
- 0099-9/98 (KIMII)-955
- Conditions
- Impact of Structured DTTP on Quality of Life, Insulin Therapy, Metabolic Control, Psychological Aspects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University of Jena
- First posted
- 7 Mar 2007 (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.
The improvement of the quality of life (QoL) is one of the key treatment goals in patients with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes mellitus. Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic therapy were successively recruited and participated in the structured inpatient diabetes treatment and teaching program (DTTP) for insulin therapy QoL was assessed before and six months after participation in the DTTP with the standardised questionnaire of Lohr analysing the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles.
Detailed description
All patients with type 2 diabetes mellitus, who were older than 54 years and admitted by general practitioner to the inpatient unit of the university hospital of Jena, Germany, for participation in a structured DTTP for insulin therapy because of hyperglycemia, were candidates for successive inclusion in the study. All patients participated in a five day inpatient structured DTTP for single or split dose administration of intermediate-acting insulin which included instruction in insulin injection, self- monitoring, hypoglycemia, acute/late complications, nutrition and foot care. Quality of life was assessed by using a validated instrument, the standardised QoL- questionnaire of Lohr et al. (21) both before and six months after participation in the DTTP. This questionnaire consists of 58 Likert- scaled items comprising the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles. Higher scores reflect higher quality of life with 100% as an optimum quality of life. The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 54 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetes mellitus, insulin therapy, age >54 years, hyperglycemia
Key exclusion criteria (1 listed)
- dementia, severe neurological deficits, polioencephalitis, rejection of informed consent
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 |
|---|---|---|
| Structured diabetes teaching and treatment program | Behavioural | – |
Primary outcome
The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.
1 secondary outcome
A secondary objective of the study was the comparison of QoL- subscale in patients already on insulin therapy with those newly on insulin therapy.
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 7 Mar 2007.
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.
Ulrich Müller, MD principal investigator
University of Jena
Anke Braun, MD study chair
Bethanien Hospital Heidelberg, Germany
Ralf Schiel, MD study chair
Inselklinik Heringsdorf, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Structured diabetes teaching and treatment program in people with Impact of Structured DTTP on Quality of Life and Insulin Therapy, run by Heidelberg University.
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 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 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.. 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 7 Mar 2007.