The effect of diabetes education tailored to nurses in psychiatry
| ISRCTN | ISRCTN15523920 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15523920 |
- Submission date
- 19/09/2019
- Registration date
- 02/10/2019
- Last edited
- 19/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Diabetes is more prevalent and insufficient treated among individuals with severe mental illness, and it is an important risk for heart diseases and premature death. On average individuals with severe mental illness die 15-20 years earlier than people without severe mental illness. The aim of the present study is to develop a diabetes education tailored to psychiatric nurses and investigate the effectiveness of the education to determine whether this will lead to better diabetes care among people with both severe mental illness and diabetes.
Who can participate?
People with severe mental illness and diabetes treated in one of the eight selected psychiatric outpatient clinics are all eligible to participate.
What does the study involve?
The study involves three consecutive days of diabetes education provided to all psychiatric nurses at four psychiatric out-patient clinics in Denmark. The effectiveness of the diabetes education is measured based on differences in quality of diabetes care in people with severe mental illness and diabetes treated at psychiatric outpatient clinics where all psychiatric nurses have participated in the diabetes education compared to psychiatric outpatient clinics where the psychiatric nurses have not participated in the diabetes education.
What are the possible benefits and risks of participating?
Benefits: For the psychiatric nurses to gain more knowledge and skills in diabetes treatment.
For people with severe mental illness and diabetes, participating in the study, the benefit of participating is to gain better quality of diabetes care.
There is no risk of participating in the study as there is no extra blood test or other clinical test involved in this study. All the participants are asked to is to complete a baseline questionnaire and four follow-up questionnaires two years after the intervention. Moreover, the participants will give the research team access to data from the Danish Health care platform (medical journals) regarding their diabetes treatment and treatment of the psychiatric disease(s). The data will be stored in accordance with the GDPR regulations.
Where is the study run from?
Steno Diabetes Center Copenhagen, Denmark
When is the study starting and how long is it expected to run for?
April 2018 to March 2022
Who is funding the study?
1. The education department of Steno Diabetes Center Copenhagen
2. Jascha Foundation
Who is the main contact?
Lenette Knudsen
lenette.knudsen@regionh.dk
Contact information
Public
Niels Steensensvej 4
Gentofte
2820
Denmark
 ORCID ID |
0000-0001-8969-4640 |
|---|---|
| Phone | +45 (0)61396888 |
| lenette.knudsen@regionh.dk |
Scientific
Niels Steensensvej 4
Gentofte
2820
Denmark
| ORCID ID |
0000-0001-8969-4640 |
|---|---|
| Phone | +45 (0)61396888 |
| lenette.knudsen@regionh.dk |
Study information
| Study design | Single-center interventional pragmatic non-randomized controlled cluster study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The effectiveness of Diabetes Education tailored to nurses in PSYchiatry (DEPSY): a pragmatic non-randomised controlled cluster study |
| Study acronym | DEPSY |
| Study hypothesis | The overall hypothesis is that the intervention, the diabetes education, will improve indicators of quality of diabetes care measured on individuals with diabetes and severe mental illness in the intervention cluster during 12- and 24-months follow-up after the intervention. |
| Ethics approval(s) | The study was submitted to ethical approval (Region Hovedstaden, Center for Sundhed, De Videnskabsetiske Komiteer, Kongens Vaenge 2, 3400 Hillerod, Denmark; +45 38 66 63 95; vek@regionh.dk) but Ethical Committee assessed the study as a quality development study and was therefore not assessed by the ethical committee |
| Condition | Diabetes and severe mental illness |
| Intervention | The intervention is a 3-day diabetes education tailored to psychiatric nurses in psychiatric outpatient clinics. The diabetes education is provided to all nurses employed at four psychiatric outpatient clinics, approximately 70 nurses in total. The education aims to improve the quality of diabetes treatment for individuals with severe mental illness and diabetes. The overall aim of the education is to improve the nurses’ diabetes knowledge and skills. The aim of the education is to provide the nurses with knowledge and skills which will give them the ability to identify and judge physical, mental and social changes for patients with severe mental illness and diabetes and support the patient in obtaining appropriate treatment of diabetes. The education is developed and conducted by the Department of Education at Steno Diabetes Center Copenhagen. The development of the intervention is based on a needs assessment lead by a team of both education and diabetes specialists (nurses, medical doctor, dietician and podiatrist) and health education researchers from the Department of Education to establish the nurses’ current knowledge, skills and usual clinical practice. All nurses from the psychiatric outpatient clinics in the intervention group will participate in the intervention from February 2019 until December 2019. The control group will receive standard of care, as provided by the Danish Health Care System which provides universal care to all. The intervention group and control group were allocated in accordance with the regional organisation of psychiatric wards where it was possible to deliver the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Number of measurements and change in HbA1c levels collected two years prior to the intervention (baseline) and every 6 months 2 years after the intervention 2. Patient-reported outcomes measured in questionnaires collected one time before the intervention (baseline) and once every 6 months 2 years after the intervention. The patient-reported outcomes are based on the following scales SDSCA, PAID5, DAWN2 (tailored to people with both severe mental illness and diabetes), PACIC (tailored to people with both severe mental illness and diabetes), CARE (tailored to people with both severe mental illness and diabetes), WHO5 and SF36 and two new questions has been developed for the present study: On a scale from 1 to 10 how much does diabetes impact your everyday life? How relevant is it to receive diabetes-related support from your psychiatric nurse from the psychiatric outpatient clinic? |
| Secondary outcome measures | Measured two years before the intervention and every 6 months 2 years after the intervention: 1. Change in number of measured lipids, urine albumin /creatinine ratio, blood pressure, weight and BMI collected from electronic patient journals 2. Change in levels of lipids, urine albumin/creatinine ratio, blood pressure, weight and BMI collected from electronic patient journals 3. Change in number of prescriptions on diabetes-related medicine (glucose-, lipids and blood pressure lowering medicine) collected from electronic patient journals 4. Change in proportion of patients screened for diabetes complications collected based on questionnaires |
| Overall study start date | 01/03/2018 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Two groups: Intervention group: approx. 60 Individuals ≥ 18 years with type 1 or type 2 diabetes and severe mental illness treated in one of the four psychiatric outpatient clinics, where the psychiatric nurses have completed the diabetes education. Control group: approx. 60 Individuals ≥ 18 years with type 1 or type 2 diabetes and severe mental illness treated in one of the four psychiatric outpatient clinics, where the psychiatric nurses have not received diabetes education |
| Total final enrolment | 107 |
| Participant inclusion criteria | 1. Individuals diagnosed with diabetes and severe mental illness 2. Treated in one of the eight psychiatric outpatient clinics in the recruitment period 3. Aged >=18 years |
| Participant exclusion criteria | 1. Patients without diabetes 2. Patients not in the psychiatric outpatient clinics 3. Patients who do not wish to participate |
| Recruitment start date | 30/08/2018 |
| Recruitment end date | 01/06/2019 |
Locations
Countries of recruitment
- Denmark
Study participating centres
Maglevænget 2
Ballerup
2750
Denmark
Søborg
2860
Denmark
Hillerød
3400
Denmark
Helsingør
3000
Denmark
København NV
2400
Denmark
Frederiksberg
2000
Denmark
København Ø
2100
Denmark
København N
2200
Denmark
Sponsor information
Hospital/treatment centre
Niels Steensensvej 4
Gentofte
2820
Denmark
| Phone | +45 (0)39 68 08 00 |
|---|---|
| SDC-FP-STENOINFO@REGIONH.DK | |
| Website | https://www.sdcc.dk/ |
"ROR" |
https://ror.org/03w7awk87 |
Charity
Vedbæk stationsvej 18
Vedbæk
2950
Denmark
| Phone | +45 (0)7020 5599 |
|---|---|
| info@jaschafonden.dk | |
| Website | https://jaschafonden.dk/ |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to national and regional data protection guidelines it is not possible to share the data even though the data is pseudonymised |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 528 | 17/11/2023 | Yes | No | |
| Other publications | 652 | 17/11/2023 | Yes | No | |
| Other publications | Observational cross-sectional study | 25/01/2022 | 17/11/2023 | Yes | No |
| Results article | 18/11/2024 | 19/11/2024 | Yes | No |
Editorial Notes
19/11/2024: Publication reference added.
17/11/2023: Publication references added.
14/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 31/03/2022.
2. The intention to publish date was changed from 01/06/2022 to 31/01/2024.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
30/09/2019: Trial’s existence confirmed by Region Hovedstaden
