Diabetes MellitusNCT00326222
Patient Education in NorthTrondelag Hospital Trust
A study testing Lifestyle counseling in people with Diabetes Mellitus, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this randomised open study is to examine the effect of self-management program for diabetes patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteNorway
- Study dates
- May 2006to Nov 2008
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ICPC-2, code T89 - diabetes dependent on insulin and T90 diabetes not dependent on insulin
Who cannot join
- Diagnosed with ICPC-2, code T89 - diabetes mellitus juvenile and diabetes I
- Attended self-management program previous 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education in NorthTrondelag Hospital Trust - Interventions, Effects and Patient Experience
The purpose of this randomised open study is to examine the effect of self-management program for diabetes patients.
Read the detailed description
The primary aim in this study is HbA1c in addition to secondary aims like quality of life and coping.
- Conditions
- Diabetes Mellitus
- Being tested
- Lifestyle counseling
- Keywords
- Patient Education as a Topic, Self-Management Program, Health promotion, Self Efficacy, Quality of life
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
Also called Self-management
Self-management group education
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lifestyle counseling Receives: Behavioral: Lifestyle counseling |
| 2 | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: Baseline, 6, and 12 mds
PAM - Patient activation measure
Measured: Baseline, 6, and 12 mds
Secondary outcomes (13)
SF36
Measured: Baseline, 6, and 12 mds
EQ 5D-VAS scale
Measured: Baseline, 6, and 12 mds
Hunt diabetes
Measured: Baseline, 6, and 12 mds
WHO-DTSQ
Measured: Baseline, 6, and 12 mds
Knowledge of diabetes
Measured: Baseline, 6, and 12 mds
HDL-cholesterol
Measured: Baseline, 6, and 12 mds
Total cholesterol
Measured: Baseline, 6, and 12 mds
Creatinin
Measured: Baseline, 6, and 12 mds
Blood pressure
Measured: Baseline, 6, and 12 mds
Weight
Measured: Baseline, 6, and 12 mds
BMI
Measured: Baseline, 6, and 12 mds
Cost/benefit
Measured: Baseline, 6, and 12 mds
Triglyceride
Measured: Baseline, 6, and 12 mds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2008
- Study completionNov 2008
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, PhD, Principal investigator, Norwegian University of Science and TechnologyLisbeth O Rygg, Master, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326222
- Sponsor's protocol ID
- PASOPP1
- Status last verified
- Jul 2016
- First submitted
- 15 May 2006
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rygg LO, Rise MB, Gronning K, Steinsbekk A. Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Patient Educ Couns. 2012 Jan;86(1):98-105. doi: 10.1016/j.pec.2011.04.008. Epub 2011 May 17.
PubMed 21592715
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education in NorthTrondelag Hospital Trust - Interventions, Effects and Patient Experience
- ClinicalTrials.gov ID
- NCT00326222
- Acronym / sponsor ID
- PASOPP1
- Conditions
- Diabetes Mellitus
- Keywords
- Patient Education as a Topic, Self-Management Program, Health promotion, Self Efficacy, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- May 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 16 May 2006 (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 purpose of this randomised open study is to examine the effect of self-management program for diabetes patients.
Detailed description
The primary aim in this study is HbA1c in addition to secondary aims like quality of life and coping.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle counselingLifestyle counseling |
| 2 | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with ICPC-2, code T89 - diabetes dependent on insulin and T90 diabetes not dependent on insulin
Key exclusion criteria (2 listed)
- Diagnosed with ICPC-2, code T89 - diabetes mellitus juvenile and diabetes I
- Attended self-management program previous 12 months
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 |
|---|---|---|
| Lifestyle counselingAlso: Self-managementSelf-management group education | Behavioural | 1 |
Primary outcome
HbA1c
Time frame: Baseline, 6, and 12 mds
PAM - Patient activation measure
Time frame: Baseline, 6, and 12 mds
13 secondary outcomes
SF36
Time frame: Baseline, 6, and 12 mds
EQ 5D-VAS scale
Time frame: Baseline, 6, and 12 mds
Hunt diabetes
Time frame: Baseline, 6, and 12 mds
WHO-DTSQ
Time frame: Baseline, 6, and 12 mds
Knowledge of diabetes
Time frame: Baseline, 6, and 12 mds
HDL-cholesterol
Time frame: Baseline, 6, and 12 mds
Total cholesterol
Time frame: Baseline, 6, and 12 mds
Creatinin
Time frame: Baseline, 6, and 12 mds
Blood pressure
Time frame: Baseline, 6, and 12 mds
Weight
Time frame: Baseline, 6, and 12 mds
BMI
Time frame: Baseline, 6, and 12 mds
Cost/benefit
Time frame: Baseline, 6, and 12 mds
Triglyceride
Time frame: Baseline, 6, and 12 mds
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 19 Jul 2016.
- Results publication: PubMed 21592715Rygg LO, Rise MB, Gronning K, Steinsbekk A. Efficacy of ongoing group based diabetes self-management education for patients with type 2 diabetes mellitus. A randomised controlled trial. Patient Educ Couns. 2012 Jan;86(1):98-105. doi: 10.1016/j.pec.2011.04.008. Epub 2011 May 17.
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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.
Aslak Steinsbekk, PhD principal investigator
Norwegian University of Science and Technology
Lisbeth O Rygg, Master principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Diabetes Mellitus, run by Norwegian University of Science and Technology at 1 site in Norway.
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: finished, as of the sponsor's last update on 19 Jul 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 Norway. 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?
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?
HbA1c (time frame: Baseline, 6, and 12 mds). The study lists 2 primary outcomes in all. 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 NCT00326222, 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 19 Jul 2016.