Can Diabetes Distress be Reduced by Improving Entry to Care for Type 2 Diabetes Patients

NCT05571306 | Unknown DMC

• 1 other identifier: 11.562
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Diabetes Distress

Keywords

Diabetes Distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of Care reported by the patients

  measured at baseline, 4, and 12 months

• Changes in Self-management measured by the Patient Activation Measure questionnaire

  measured at baseline, 4, and 12 months

• Changes in the SF-12 (Quality of life)

  measured at baseline, 4, and 12 months

• Changes in Self-care measured using the Summary of Diabetes Self-Care Activities Measurement questionnaire

  measured at baseline, 4, and 12 months

• Changes in HbA1c

  measured at baseline, 4, and 12 months

Other Outcomes (4)

• Changes in Stress scale

  measured at baseline, 4, and 12 months

• Changes in Major Depression Inventory

  measured at baseline, 4, and 12 months

• Changes in Social Network scale

  measured at baseline, 4, and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Receives a three month intervention.

Other: four core components care

Care as usual

NO INTERVENTION

This arm is given care as usual provided at a General Practice in Denmark.

Interventions

four core components care OTHER

The intervention progresses throughout the first three months for the recently diagnosed T2DM patients and is divided into four core components: 1) Improve of cross-sectoral communication and information sharing, 2) ensure systematism in care, 3) guarantee participation at a "one-stop-shop" and a start-up conversation at the municipality, and 4) improve patients coping skills.

Also known as: Entry to care

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand Danish
• Diagnosed according to Danish guidelines

You may not qualify if:

• General Practitioners enrolled for the DD2 project.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

University of Soutern Denmark

Odense C, 5000, Denmark

RECRUITING

Related Publications (14)

• 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.

  PMID: 28799294 BACKGROUND

• 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.

  PMID: 31638279 BACKGROUND

• 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.

  PMID: 29895167 BACKGROUND

• 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.

  PMID: 29947921 BACKGROUND

• 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.

  PMID: 24605197 BACKGROUND

• 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.

  PMID: 26287511 BACKGROUND

• 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.

  PMID: 28159442 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 10895844 BACKGROUND

• 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.

  PMID: 16641618 BACKGROUND

• 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.

  PMID: 32799656 BACKGROUND

• 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.

  PMID: 21924576 BACKGROUND

• 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.

  PMID: 29085540 BACKGROUND

• Hansen SH, Jensen TM, Petersen GS, Pouwer F, Larrabee Sonderlund A, Sondergaard J. Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial. Trials. 2024 Mar 21;25(1):207. doi: 10.1186/s13063-024-07949-6.

  PMID: 38515146 DERIVED

Related Links

• The cross-sectoral course programme for patients with type 2 diabetes - Region of Southern Jutland.
• The Danish diabetes association with a report on the life with type 2 diabetes
• The national research centre on welfare with a report on the life with type 2 diabetes
• National Knowledge Centre on Dementia and information about the outcome Major Depression Inventory
• Description of the LSNS outcome measure.
• Description of the CD-RISC outcome measure.
• Information about e-Boks
• Where the clinical results are recieved.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jens Søndergaard, Phd

  Research Unit of General Practice (University of Southern Denmark)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffan Holst Hansen, Master

CONTACT

T +45 65 50 36 19; sholsthansen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients are blinded to what treatment their are given and the investigator and outcome Assessor is likewise blinded as each patients and general practices are annonymized..
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As the study is a cluster randomized trial, General Practitioners are those being allocated for either intervention or control (care as usual), with controls being enrolled as late intervention.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 7, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)