Viewing Study NCT05571306



Ignite Creation Date: 2024-05-06 @ 6:11 PM
Last Modification Date: 2024-10-26 @ 2:43 PM
Study NCT ID: NCT05571306
Status: RECRUITING
Last Update Posted: 2023-06-18
First Post: 2022-09-28

Brief Title: Can Diabetes Distress be Reduced by Improving Entry to Care for Type 2 Diabetes Patients
Sponsor: University of Southern Denmark
Organization: University of Southern Denmark

Study Overview

Official Title: Can Diabetes Distress be Reduced by Improving Entry to Care for People With Type 2 Diabetes Mellitus A Cluster-randomized Trial
Status: RECRUITING
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: 1 Background When diagnosed with type 2 diabetes mellitus T2DM patients face numerous challenges such as emotional reactions to the diagnosis acquiring new knowledge to better comprehend the disease management of the disease altering of diet fear of complications and potentially disrupted relationships with family and friends To support these patients care recommendations are clearly defined in the clinical guidelines for the treatment of T2DM 12 It is suggested that three consultations with the general practice GP are adequate to provide the patient with information about the disease disease management and treatment Moreover patients are recommended to be referred for health-education programs lifestyle interventions and complication screenings 1 However it has been reported that a large proportion of patients are in fact not referred to these programs in the municipalities even though they explicitly wanted to 3 Also the continuity of care and cross-sectoral collaboration between sectors have been reported to be deficient with patients requesting more cross-sectoral collaboration and information sharing 4 These shortcomings in the organizational structure of diabetes care may result in psychological or psychosocial complications such as depression andor diabetes-related distress DD Diabetes distress is the most prevalent complication in T2DM patients with 36 reporting high or severe levels of DD 56 Diabetes distress refers to the negative emotional experiences resulting from receiving the disease and the challenges of living with diabetes in day-to-day activities DD is positively associated with glycemic control and self-care increasing the risk of complications and the higher the level of DD 7

Additionally recent studies point towards an association between high levels of DD and increased mortality rate among men 8 Thus it is of immense importance to address DD timely to preventreduce further exacerbation which might lead to more severe complications Hence this project evaluates a structural entry-to-care intervention created by Steno Diabetes Centre Odense SDCO aiming at increasing the cross-sectoral collaboration and structuring of the treatment of the first three months when diagnosed while reducing DD among recently diagnosed T2DM patients The intervention will facilitate cross-sectoral collaboration provide novel data-driven individualized recommendations to GPs guidelines and checklists for patients and inclusion of the one-stop-shop
2 Design and Methods A Design The design is a cluster-randomized controlled trial conducted in the primary- and secondary sectors in the Region of Southern Denmark It is designed to examine the effect of a structured start-up routine on recently diagnosed T2DM patients GP will be randomly allocated to either intervention or control

B Intervention 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

B1 Improve cross-sectoral communication and information sharing To increase cross-sectoral communication and information sharing meetings between GP municipalities and regional hospitals will be facilitated by SDCO Based on previous reports by SDCO patients did not experience satisfactory cross-sectoral collaboration as part of their treatment indeed coherence of treatment was for some patients non-existing Coherence to treatment has a positive and negative association with DD severity 6 Hence the cross-sectoral meetings include knowledge sharing concerning the specific healthcare services each sector provides regarding the treatmentcare of the recently diagnosed T2DM patients

These elements are expected to increase the cross-sectoral collaboration thus increasing care coherence felt by the patients

B2 Systematism in care To ensure systematism and uniformity in the care given to all recently diagnosed T2DM patients clear guidelines developed from present recommendations by SDCO are given to each GP Appendix 3 Guidelines for general practice The guidelines act as a framework of what advisable information patients are to be given at the first four consultations Additionally each GP is invited to an individual meeting with SDCO where requirements and needs are discussed thus tailoring the implementation to each GPs individual needs

B3 A one-stop-shop and a start-up conversation at the municipality The report mentioned in B1 further stated that GP failed to refer patients for the start-up conversation at the municipalities either because the GP was unaware of the proposal or due to them being uncertain of the service quality It is known that levels of DD improve if patients participate in health-related education 6 thus it is of great importance that GP does refer patients for a start-up conversation in the municipality as they are delivering these education programs Hence GP must refer all patients for a start-up conversation at the municipality and for a one-stop-shop an opportunity for patients to complete several required examinations eg blood samples blood pressure measurement eye and feet screening during one appointment These referrals do ensure automatization in the treatment of T2DM and it provides the patients with the premises of improved care

B4 Improvements of patients coping skills Patient information material has been developed by SDCO in collaboration with TD2M patients This provides the patients with a greater sense of coherence structure and overview of the first period with their new disease and consists of 1 a checklist ensuring that patients are given the mandatory information concerning any question they might have Appendix 4 Checklist for patients 2 a graphical guide throughout the first period with the disease Flowchart of patient flow - the same as above and 3 basic information about the disease Steno Pjece Quick guide - Danish version All material is designed to support the patients in the uncertainty right after the diagnosis and thus providing them a greater understanding and transparency of the disease which in turn should minimize the levels of DD by increasing their coping skills

C Method This project evaluates the effects of a structural entry-to-care intervention compared to usual in its ability to reduce DD among recently diagnosed T2D patients Appendix 5 Flow of randomization SDCO is responsible for the recruitment of GPs within the Region of Southern Denmark GPs agreeing upon participation will be randomized for intervention or control clusters with a 11 allocation ratio using a random computer-generated block size of six 9

GPs are stratified into two groups the first including GPs with one or two capacities and the second with three or more capacities GPs included in the digital individualized and collaborative treatment of T2DM in general practice DICTA intervention will be excluded thus minimizing contamination between interventions This study requires 32 clusters 16arm to achieve 80 power and a 5 significance cut-off with 270 patients required GP recruitment occurred from May-Dec 2022 Patient recruitment is ongoing from May 2022 to Aug 2023 GPs were randomized 11 using computer-generated blocks of six Patients included must be 18 years understand Danish and be diagnosed according to Danish guidelines The intervention group will receive a three-month individualized treatment while the control receives treatment as usual

D Effect Evaluation The outcomes displayed below were chosen as they are validated tools measuring their area of capability and have all been validated in Danish

D1 Primary outcome measured at baseline 4 and 12 months appendix 6 measure overview

Changes in DD levels measured using the diabetes distress scale DDS 10 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 Diabetes distress was chosen as the primary outcome due to it being associated with several health indicators such as the level of self-care diet exercise etc quality of life self-management HbA1c blood lipids depression severe complications and all-cause mortality

D2 Secondary outcomes measured at baseline 4 and 12 months

Improvements in the perceived quality of care will be measured through self-made questions
Improvements in self-management measured by the Patient Activation Measure as positively related to health outcomes such as HbA1c lipids and blood pressure 11
Improvements in quality of life will be measured using the 12-item short-form survey 12 This was chosen as a measure that is comparable with the Danish population
Improvements in self-care measured using the Summary of Diabetes Self-Care Activities Measurement 13 was chosen as self-care has been reported to be positively associated with DD
Improvements in the clinical components HbA1c blood pressure blood lipids and EKG is to be measured

D3 Tertiary outcome Levels of depression and stress measured by the Major Depression Inventory 14 and the 2-item Stress Scale 15 respectively as patients with a higher level of depression and stress have increased levels of DD 16 therefore a planned examination of the association between depression stress and DD at baseline 4 and 12 months follow-up will be conducted Additionally the level of social support measured using the Lubben Social Network Scale and the level of resilience measured using the Conner-Davidson Resilience Scale will likewise be compared with the levels of DD at the same time point as higher perceived social support and resilience have been reported to be associated with lower DD levels

D4 Potential covariates including sex age nationality clinical and biochemical measures education status marital status comorbidity smoking physical activity employment status depression social network and sleep quantity and quality

Patient-reported outcomes will be collected through an electronic survey distributed individually to the patients e-Boks 19 Clinical and biochemical measures such as blood pressure and HbA1c will be collected through the clinical laboratory information system 20 and clinical biochemistry departments These data will be linked to sociodemographic data via Statistics Denmark

E Sample size The total number of clusters needed is calculated based on means and standard deviations from previous studies 21 A low cluster interclass correlation 01 and a mean group cluster size of 8 the total number of T2DM patients each capacitate observe per year in both the control and intervention group is expected With a power of 80 a dropout rate of 20 and a significance level of 5 64 clusters 32 In each and 512 patients are required for the analysis

F Data analysis All analyses will be performed as intention-to-treat 22 The Generalized Estimating Equations model GEE will be used for the analysis taking the cluster randomization into account The model will be adjusted for the main potential confounders The GEE analysis will be performed using STATABE Version 17 The level of statistical significance will be P 005 To support future hypotheses several ad-hoc analyses will be conducted as required

G Limitations The requirement that patients must understand Danish excludes individuals which previously have been reported to have the highest level of DD 6 and who potentially would benefit most from the intervention

This project mainly consists of patient-reported outcomes which increases the risk of drop-out due to the length of the questionnaire

Clinical outcomes might not provide notable changes before two years of follow-up

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None