Type 2 Diabetes Clinical Trial
Official title:
Can Diabetes Distress be Reduced by Improving Entry to Care for People With Type 2 Diabetes Mellitus: A Cluster-randomized Trial
Care recommendations for type 2 diabetes mellitus (T2DM) patients are clearly defined in Danish clinical guidelines: patients are offered three consultations with the general practice (GP), patients must be referred for a municipal start-up conversation, and cross-sectoral collaboration is vital to succeeding in the treatment of T2DM patients. This framework is often reported as inadequate by the patients, which increases the risk of high levels of diabetes distress (DD). Diabetes distress is the burden of living with T2DM and is associated with deleterious physical and mental health outcomes, including poor glycemic control, recurved wellbeing, and increased all-course mortality. This project evaluates the efficacy of an entry-to-care intervention, seeking to strengthen and structure the cross-sectoral collaboration, targeting DD in people recently diagnosed with T2DM. Intervention The intervention progresses throughout the first three months of the diagnosis. It is divided into core components: Improvements of cross-sectoral communication and information sharing, ensure systematism in care, guarantee participation at a "one-stop-shop" and a start-up conversation at the municipal, and improve patients coping skills. Research plan This cluster-randomized control trial is conducted in the Region of Southern Denmark, with each GP randomly assigned to intervention or control. Changes in DD are the primary outcome. Data will be collected through an electronic questionnaire at baseline and 4, 12 months after diagnosis. Perspective and expected outcomes A decrease in DD levels causes; higher level of self-care, quality of life, self-management, glycemic control and decrease the risk of severe complications and all-cause mortality. The intervention will be extrapolated to other patient groups where cross-sectoral collaboration is part of the care, increasing the treatment for these patient groups as well.
Status | Recruiting |
Enrollment | 512 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Understand Danish - Diagnosed according to Danish guidelines Exclusion Criteria: - General Practitioners enrolled for the DD2 project. |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Soutern Denmark | Odense C |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
Glasgow RE, Kurz D, King D, Dickman JM, Faber AJ, Halterman E, Woolley T, Toobert DJ, Strycker LA, Estabrooks PA, Osuna D, Ritzwoller D. Twelve-month outcomes of an Internet-based diabetes self-management support program. Patient Educ Couns. 2012 Apr;87(1):81-92. doi: 10.1016/j.pec.2011.07.024. Epub 2011 Sep 15. — View Citation
Hayashino Y, Okamura S, Tsujii S, Ishii H; Diabetes Distress and Care Registry at Tenri Study Group. Association between diabetes distress and all-cause mortality in Japanese individuals with type 2 diabetes: a prospective cohort study (Diabetes Distress and Care Registry in Tenri [DDCRT 18]). Diabetologia. 2018 Sep;61(9):1978-1984. doi: 10.1007/s00125-018-4657-4. Epub 2018 Jun 8. — View Citation
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14. — View Citation
Littman AJ, White E, Satia JA, Bowen DJ, Kristal AR. Reliability and validity of 2 single-item measures of psychosocial stress. Epidemiology. 2006 Jul;17(4):398-403. doi: 10.1097/01.ede.0000219721.89552.51. — View Citation
McCoy CE. Understanding the Intention-to-treat Principle in Randomized Controlled Trials. West J Emerg Med. 2017 Oct;18(6):1075-1078. doi: 10.5811/westjem.2017.8.35985. Epub 2017 Sep 18. — View Citation
Peimani M, Nasli-Esfahani E, Sadeghi R. Patients' perceptions of patient-provider communication and diabetes care: A systematic review of quantitative and qualitative studies. Chronic Illn. 2020 Mar;16(1):3-22. doi: 10.1177/1742395318782378. Epub 2018 Jun 12. No abstract available. — View Citation
Perrin NE, Davies MJ, Robertson N, Snoek FJ, Khunti K. The prevalence of diabetes-specific emotional distress in people with Type 2 diabetes: a systematic review and meta-analysis. Diabet Med. 2017 Nov;34(11):1508-1520. doi: 10.1111/dme.13448. Epub 2017 Aug 31. — View Citation
Sacks RM, Greene J, Hibbard J, Overton V, Parrotta CD. Does patient activation predict the course of type 2 diabetes? A longitudinal study. Patient Educ Couns. 2017 Jul;100(7):1268-1275. doi: 10.1016/j.pec.2017.01.014. Epub 2017 Jan 25. — View Citation
Schmitt A, Reimer A, Kulzer B, Haak T, Ehrmann D, Hermanns N. How to assess diabetes distress: comparison of the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS). Diabet Med. 2016 Jun;33(6):835-43. doi: 10.1111/dme.12887. Epub 2015 Sep 8. — View Citation
Skinner TC, Joensen L, Parkin T. Twenty-five years of diabetes distress research. Diabet Med. 2020 Mar;37(3):393-400. doi: 10.1111/dme.14157. Epub 2019 Oct 31. — View Citation
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943. — View Citation
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. — View Citation
Yang QQ, Sun JW, Shao D, Zhang HH, Bai CF, Cao FL. The Association between Diabetes Complications, Diabetes Distress, and Depressive Symptoms in Patients with Type 2 Diabetes Mellitus. Clin Nurs Res. 2021 Mar;30(3):293-301. doi: 10.1177/1054773820951933. Epub 2020 Aug 17. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in Stress scale | Level of stress measured by the 2-item Stress Scale | measured at baseline, 4, and 12 months | |
Other | Changes in Major Depression Inventory | Level of depression measured by the Major Depression Inventory | measured at baseline, 4, and 12 months | |
Other | Changes in Social Network scale | The level of social support measured using the Lubben Social Network Scale | measured at baseline, 4, and 12 months | |
Other | Changes in Resilience measured using the Conner-Davidson Resilience Scale | measured at baseline, 4, and 12 months | ||
Primary | Changes in Diabetes Distress levels | Changes in DD levels measured using the diabetes distress scale (DDS). The DDS scale was designed to measure the level of diabetes-related distress and potential contributing factors such as 'physician-related distress', 'regimen-related distress' etc.. | measured at baseline, 4, and 12 months | |
Secondary | Quality of Care reported by the patients | Changes in the perceived quality of care will be measured through self-made questions. | measured at baseline, 4, and 12 months | |
Secondary | Changes in Self-management measured by the Patient Activation Measure questionnaire | Changes in self-management measured by the Patient Activation Measure | measured at baseline, 4, and 12 months | |
Secondary | Changes in the SF-12 (Quality of life) | Changes quality of life will be measured using the 12-item short-form survey. This was chosen as a measure that is comparable with the Danish population | measured at baseline, 4, and 12 months | |
Secondary | Changes in Self-care measured using the Summary of Diabetes Self-Care Activities Measurement questionnaire | Changes in self-care measured using the Summary of Diabetes Self-Care Activities Measurement was chosen as self-care has been reported to be positively associated with DD | measured at baseline, 4, and 12 months | |
Secondary | Changes in HbA1c | Changes in HbA1c will be measured in mmol/l | measured at baseline, 4, and 12 months | |
Secondary | Changes in Blood pressure | Changes in systolic and diastolic blood pressure will be measured in mmHg. | Measured at baseline, 4, and 12 months | |
Secondary | Changes in Blood lipds | Changes in low-density lipoprotein (LDL) and high-density lipoprotein (HDL) will be measured. | Measured at baseline, 4, and 12 months |
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