Type 2 DiabetesDiacourseNCT01801631
Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
A study testing Home visits and Consultation by telephone in people with Type 2 Diabetes and Acute Coronary Event, run by UMC Utrecht at 13 sites in Netherlands.
Trial summary
Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result in a decreased quality of life and increased distress. According to the American Diabetes Association, transition from the acute care setting is a high-risk time for all patients, but tailored support specific to diabetes is… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes, Acute Coronary Event
- What is being tested?
- Home visits and Consultation by telephone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 13 sitesNetherlands
- Study dates
- Oct 2011to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of type 2 diabetes (>1 year)
- Discharged from the hospital after a first acute coronary event defined as a Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) procedure or Percutaneous Transluminal Coronary Angioplasty (PTCA)
- Sufficient knowledge of the Dutch language
Who cannot join
- A serious illness or condition which will prevent full participation
- Not able to fill in questionnaires
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
Meander Medical Center
Amersfoort
Gelre Hospitals
Apeldoorn
Lievensberg Hospital
Bergen op Zoom
Amphia Hospital
Breda
Gemini Hospital
Den Helder
Admiraal de Ruyter Hospital
Goes
Beatrix Hospital
Gorinchem
Westfriesgasthuis
Hoorn
Sint Antonius Hospital
Nieuwegein
Canisius Wilhelmina Hospital
Nijmegen
Diakonessenhuis
Utrecht
Sint Antonius Hospital
Utrecht
University Medical Center
Utrecht
About this study
Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result in a decreased quality of life and increased distress. According to the American Diabetes Association, transition from the acute care setting is a high-risk time for all patients, but tailored support specific to diabetes is scarce in that period. The investigators developed an intervention by a diabetes nurse to help diabetic patients reduce distress after their first ACE. The intervention is based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and on results of focus groups which were conducted to define the needs and wishes of type 2 diabetes patients and their partners regarding professional support after an ACE. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress. The hypothesis is that patients who receive the intervention will have less diabetes related distress compared to the control group.
Methods/Design: Randomized controlled trial. Patients will be recruited directly after discharge from hospital. A diabetes nurse will visit the patients in the intervention group (n = 100) within three weeks after discharge from hospital, two weeks later and two months later. The control group (n = 100) will receive a telephone consultation. The primary outcome is diabetes related distress, measured with the Problem Areas in Diabetes questionnaire (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Variables will be measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables will be obtained from the records from the primary care physician and the hospital. Differences between groups in change over time will be analyzed according to the intention-to-treat principle.
Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence of the effectiveness of a supportive intervention to reduce distress in these patients.
Read the detailed description
See citation design paper
- Conditions
- Type 2 Diabetes, Acute Coronary Event
- Being tested
- Home visits, Consultation by telephone
- Keywords
- Type 2 diabetes, Acute Coronary Event (ACE), Distress, Self-efficacy, Quality of Life, Depression, Primary care, Illness representations
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitsOther
In addition to usual care the patients will receive three home visits from a trained diabetes nurse. The first visit (65 minutes) is within three weeks after discharge from the hospital; the second visit (45 minutes) is two weeks later and the third visit (45 minutes) is two months after the second home visit.
Consultation by telephoneOther
In addition to usual care patients will receive a consultation by telephone within three weeks after discharge to offer them personal attention. In this consultation they will get the opportunity to discuss in ten to fifteen minutes how they feel in the period after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Home visits | Experimental | In addition to usual care the patients will receive three home visits from a trained diabetes nurse. The first visit (65 minutes) is within three weeks after discharge from the hospital; the second visit (45 minutes) is two weeks later and the third visit (45 minutes) is two months after the second home visit. Receives: Other: Home visits |
| Consultation by telephone | Other | In addition to usual care patients will receive a consultation by telephone within three weeks after discharge to offer them personal attention. In this consultation they will get the opportunity to discuss in ten to fifteen minutes how they feel in the period after discharge. Receives: Other: Consultation by telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetes related distress
Diabetes related distress measure with the Problem Areas in Diabetes (PAID) questionnaire. The PAID is a Self-reported questionnaire consisting of twenty statements identified as common negative emotions related to living with diabetes. Each item is rated on a 5-point Likert scale, ranging from 0 ("not a problem") to 4 ("a serious problem"). The total score is transformed to a 0-100 scale, with higher score representing higher distress.
Measured: At 2 weeks and 5 months after discharge from hospital
Secondary outcomes (7)
Change in Well-being
Measured with the WHO-Five Well-being Index (WHO-5). The five items covering positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things) in the past two weeks
Measured: At 2 weeks and 5 months after discharge from hospital
Change in Quality of life
Euroqol 5 Dimensions (EQ-5D) and the Euroqol Visual Scale (EQ-VAS). The EQ-5D measures general health status on five dimensions:
- Mobility
- Self-care
- Usual activities
- Pain/discomfort
- Anxiety/depression The EQ-VAS measures the overall health state on a graded, vertical line.
Measured: At 2 weeks and 5 months after discharge from hospital
Change in Anxiety and depression
Measured with the Hospital Anxiety and Depression Scale (HADS). A questionnaire measuring anxiety (7 items) and depression (7 items).
Measured: At 2 weeks and 5 months after discharge from hospital
Change in Physical activity
Measured with the International Physical Activity Questionnaire (IPAQ). 29 Items measure how many days' physical activities are performed during the past seven days in four domains (work, transportation, housework and leisure-time).
Measured: At 2 weeks and 5 months after discharge from hospital
Change in Self care
Measured with the Summary of the Diabetes Self-Care Activities Measure (SDSCA). Eleven items assessing several aspects of the diabetes regimen: general diet, specific diet, exercise, blood glucose testing, foot care, and smoking. Items measure how many days a patient has performed self-care activities in the last seven days.
Measured: At 2 weeks and 5 months after discharge from hospital
Change in Diabetes coping
Measured with the Diabetes Coping Measure (DCM) consisting of four scales measuring diabetes coping: tackling spirit, avoidance, passive resignation and diabetes integration.
Measured: At 2 weeks and 5 months after discharge from hospital
Change in Biomedical variables
Blood pressure, blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) and body mass index
Measured: At 2 weeks and 5 months after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Responsible party
- Principal investigator, Prof. G.E.H.M. Rutten, UMC Utrecht
- Investigators
- Guy E. Rutten, Professor, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801631
- Sponsor's protocol ID
- DF2009-70
- Other IDs
- Dutch trial registration
- Acronym
- Diacourse
- Status last verified
- Jul 2014
- First submitted
- 14 Feb 2013
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kasteleyn MJ, Gorter KJ, Stellato RK, Rijken M, Nijpels G, Rutten GE. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial. Diabetol Metab Syndr. 2014 Jan 18;6(1):5. doi: 10.1186/1758-5996-6-5.
PubMed 24438342Kasteleyn MJ, Gorter KJ, van Puffelen AL, Heijmans M, Vos RC, Jansen H, Rutten GE. What follow-up care and self-management support do patients with type 2 diabetes want after their first acute coronary event? A qualitative study. Prim Care Diabetes. 2014 Oct;8(3):195-206. doi: 10.1016/j.pcd.2013.12.001. Epub 2014 Jan 3.
PubMed 24389352
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
- ClinicalTrials.gov ID
- NCT01801631
- Acronym / sponsor ID
- Diacourse / DF2009-70
- Conditions
- Type 2 Diabetes, Acute Coronary Event
- Keywords
- Type 2 diabetes, Acute Coronary Event (ACE), Distress, Self-efficacy, Quality of Life, Depression, Primary care, Illness representations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Mar 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.
Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result in a decreased quality of life and increased distress. According to the American Diabetes Association, transition from the acute care setting is a high-risk time for all patients, but tailored support specific to diabetes is scarce in that period. The investigators developed an intervention by a diabetes nurse to help diabetic patients reduce distress after their first ACE. The intervention is based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and on results of focus groups which were conducted to define the needs and wishes of type 2 diabetes patients and their partners regarding professional support after an ACE. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress. The hypothesis is that patients who receive the intervention will have less diabetes related distress compared to the control group.
Methods/Design: Randomized controlled trial. Patients will be recruited directly after discharge from hospital. A diabetes nurse will visit the patients in the intervention group (n = 100) within three weeks after discharge from hospital, two weeks later and two months later. The control group (n = 100) will receive a telephone consultation. The primary outcome is diabetes related distress, measured with the Problem Areas in Diabetes questionnaire (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Variables will be measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables will be obtained from the records from the primary care physician and the hospital. Differences between groups in change over time will be analyzed according to the intention-to-treat principle.
Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence of the effectiveness of a supportive intervention to reduce distress in these patients.
Detailed description
See citation design paper
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home visits | Experimental | Other: Home visitsIn addition to usual care the patients will receive three home visits from a trained diabetes nurse. The first visit (65 minutes) is within three weeks after discharge from the hospital; the second visit (45 minutes) is two weeks later and the third visit (45 minutes) is two months after the second home visit. |
| Consultation by telephone | Other | Other: Consultation by telephoneIn addition to usual care patients will receive a consultation by telephone within three weeks after discharge to offer them personal attention. In this consultation they will get the opportunity to discuss in ten to fifteen minutes how they feel in the period after discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- History of type 2 diabetes (>1 year)
- Discharged from the hospital after a first acute coronary event defined as a Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) procedure or Percutaneous Transluminal Coronary Angioplasty (PTCA)
- Sufficient knowledge of the Dutch language
Key exclusion criteria (2 listed)
- A serious illness or condition which will prevent full participation
- Not able to fill in questionnaires
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 |
|---|---|---|
| Home visitsIn addition to usual care the patients will receive three home visits from a trained diabetes nurse. The first visit (65 minutes) is within three weeks after discharge from the hospital; the second visit (45 minutes) is two weeks later and the third visit (45 minutes) is two months after the second home visit. | Other | Home visits |
| Consultation by telephoneIn addition to usual care patients will receive a consultation by telephone within three weeks after discharge to offer them personal attention. In this consultation they will get the opportunity to discuss in ten to fifteen minutes how they feel in the period after discharge. | Other | Consultation by telephone |
Primary outcome
Change in Diabetes related distress
Time frame: At 2 weeks and 5 months after discharge from hospital
Diabetes related distress measure with the Problem Areas in Diabetes (PAID) questionnaire. The PAID is a Self-reported questionnaire consisting of twenty statements identified as common negative emotions related to living with diabetes. Each item is rated on a 5-point Likert scale, ranging from 0 ("not a problem") to 4 ("a serious problem"). The total score is transformed to a 0-100 scale, with higher score representing higher distress.
7 secondary outcomes
Change in Well-being
Time frame: At 2 weeks and 5 months after discharge from hospital
Change in Quality of life
Time frame: At 2 weeks and 5 months after discharge from hospital
Change in Anxiety and depression
Time frame: At 2 weeks and 5 months after discharge from hospital
Change in Physical activity
Time frame: At 2 weeks and 5 months after discharge from hospital
Change in Self care
Time frame: At 2 weeks and 5 months after discharge from hospital
Change in Diabetes coping
Time frame: At 2 weeks and 5 months after discharge from hospital
Change in Biomedical variables
Time frame: At 2 weeks and 5 months after discharge from hospital
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 28 Jul 2014.
- Background: PubMed 24438342Kasteleyn MJ, Gorter KJ, Stellato RK, Rijken M, Nijpels G, Rutten GE. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial. Diabetol Metab Syndr. 2014 Jan 18;6(1):5. doi: 10.1186/1758-5996-6-5.
- Background: PubMed 24389352Kasteleyn MJ, Gorter KJ, van Puffelen AL, Heijmans M, Vos RC, Jansen H, Rutten GE. What follow-up care and self-management support do patients with type 2 diabetes want after their first acute coronary event? A qualitative study. Prim Care Diabetes. 2014 Oct;8(3):195-206. doi: 10.1016/j.pcd.2013.12.001. Epub 2014 Jan 3.
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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.
Guy E. Rutten, Professor principal investigator
UMC Utrecht
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visits and Consultation by telephone in people with Type 2 Diabetes and Acute Coronary Event, run by UMC Utrecht at 13 sites in Netherlands.
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 3 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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. 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?
Change in Diabetes related distress (time frame: At 2 weeks and 5 months after discharge from hospital). 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 NCT01801631, which also lists 2 linked publications.
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 28 Jul 2014.