NCT05495230: OPTIMAFORMA3

OPTIMA FORMA Phase 3

Completed NA Last updated 18 November 2024

What this trial tests

NA trial testing Person-centred integrated care intervention in Chronic Condition in 842 participants. Completed in 1 September 2024.

Timeline

1 January 2023

Primary endpoint
1 September 2024

1 September 2024

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	842
Start date	1 January 2023
Primary completion	1 September 2024
Estimated completion	1 September 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• Person-centred integrated care intervention
• Usual care

Conditions studied

• Chronic Condition — all drugs for Chronic Condition →
• Chronic Conditions, Multiple — all drugs for Chronic Conditions, Multiple →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Chronic Condition or Chronic Conditions, Multiple. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic diseases and multimorbidity are increasingly prevalent. However, over the last decades, attempts at improving primary care for chronic diseases have been focussed on the management of individual chronic diseases and single disease management (SDM) programs have been implemented in Dutch primary care. This causes multiple problems for patients with one or more chronic diseases, such as negative interaction between treatment of single diseases, high treatment burden, negative patient experiences, lack of attention for problems in other domains of life that may interact with the chronic disease, and difficulties in shared decision making by the use of strict protocols in SDM programs. A person-centred and holistic approach is widely recognized as the solution to the problems observed in chronic disease care. Therefore, we guided three large Dutch primary care cooperatives, who have been organizing SDM programmes on diabetes mellitus type 2 (DM2), COPD, and cardiovascular diseases (CVD) in primary care for the last decades, with the development of a new generic disease management (GDM) programme including a person-centered and holistic approach (CMO 2019-5756). The three primary care cooperatives have recently conducted a pilot study in which we evaluated the feasibility of the programme (CMO 2021-8106) to further optimise its content and procedures. In the coming years, all three primary care cooperatives will gradually implement the optimised programme in all general practices in their regions. In the current study, our aim is to evaluate the effectiveness of the GDM programme on Quadruple Aim outcomes, i.e. patient experiences, population health, health care provider experiences, and cost effectiveness. We will conduct a cluster randomized controlled trial in the three primary care cooperatives with a follow-up of 12 months. Fifteen practices will be randomised to either care as usual according to the current SDM programmes, or to the GDM programme including a person-centered and holistic care approach. Approximately 40 patients per practice with DM2, COPD and/or CVD will be recruited.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Optimizing Study Design for Evaluating Complex Interventions: An Example of a Feasibility Study in Person-Centered and Integrated Chronic Disease Care in Dutch General Practice.
   Raaijmakers LHA, Schermer TR, van Bommel HE, Vercoulen JH, et al · · 2025 · PMID 41209624 · DOI 10.5334/ijic.8998