Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Impact of Self-care Education Program "Active Patient" in Metabolic Control, Cardiovascular Risk and Quality of Life in Patients With Type 2 Diabetes in Primary Care in the Basque Country: Randomized Clinical Trial of 2 Years of Follow up
Brief Summary: Main objective:To evaluate the effectiveness of the "Diabetes Self-Management Programme" (DSMP) on the metabolic control, cardiovascular risk reduction, quality of life and self-efficacy in adult patients with type 2 diabetes, compared with current standard care of patients with type 2 diabetes, in the context of Osakidetza's Primary Care network.

Secondary objectives:

* To evaluate the impact of the implementation of DSMP in the use of health services.
* To assess the impact of DSMP in the cost of treatment of the involved population.
* To evaluate the improvement in physical activity and diet patterns among the participants.
* To describe the feasibility of implementing the DSMP in the Basque Country's primary health care system Methodology: Randomized clinical trial in which patients diagnosed with type 2 diabetes aged between 18 and 80 years pertaining to 4 primary regions of the Basque country, who agree to participate in the study, will be randomly assigned to two groups: the intervention group (the DSMP programme) and the control group. The intervention will be performed by trained patients with type 2 diabetes and health professionals and it will consist in 6 group sessions of two and a half hours each, on a weekly basis with a overall duration of 6 weeks. The session content includes techniques for dealing with problems, promotion of exercise, nutrition concepts, proper use of medication, effective communication and basic knowledge about diabetes and its complications. The sessions are supported with educational material. The main outcome is the improvement of HbA1c (glycated hemoglobin) levels. Secondary outcomes are reduction of cardiovascular risk, increase of quality of life and self-efficacy. The results will be analyzed at 6, 12 and 24 months after the intervention.

Hypothesis: An educational intervention on patients with type 2 diabetes mellitus based on the program DSMP conducted by previously trained lay persons and health professionals, improve metabolic control as measured on a 0.5% decrease in Hb A1c (Clar, 2010),compared to regular health education. On the other hand, it is expected to see improvements in the quality of life for these patients. The intervention may reduce the weight and cardiovascular risk due to changes in the physical activity and diet patterns, getting to a more appropriate use of health services and medication. It is expected that changes in the variables occur 6 months after the intervention and remain over the time


Options:
A: Arm Label: Machine and NCC; Type: EXPERIMENTAL; Interventions: Other: MD2 machine and nurse care coordination | Arm Label: Medplanner and NCC; Type: EXPERIMENTAL; Interventions: Other: Medplanner and Nurse Care Coordination | Arm Label: Usual Care Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: MD2 machine and nurse care coordination; Assigned to Arm(s): Machine and NCC | Intervention Type: OTHER; Name: Medplanner and Nurse Care Coordination; Assigned to Arm(s): Medplanner and NCC
B: Arm Label: SHHE Peridischarge intervention; Type: EXPERIMENTAL; Interventions: Behavioral: SHHE Peridischarge Intervention | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: SHHE Peridischarge Intervention; Assigned to Arm(s): SHHE Peridischarge intervention
C: Arm Label: Standardized care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Self-management education programme; Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes Self-Management Program | Intervention Type: BEHAVIORAL; Name: Diabetes Self-Management Program; Assigned to Arm(s): Self-management education programme
D: Arm Label: Usual Care-Chronic Disease Management; Type: SHAM_COMPARATOR; Interventions: Behavioral: Usual Care | Arm Label: P2E2T2 Program; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: P2E2T2 Program | Intervention Type: BEHAVIORAL; Name: Usual Care; Assigned to Arm(s): Usual Care-Chronic Disease Management | Intervention Type: BEHAVIORAL; Name: P2E2T2 Program; Assigned to Arm(s): P2E2T2 Program

Answer: C