Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
Brief Summary: Objective:

* To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
* To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.

Methodology:

Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.


Options:
A: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: mHealth Risk Assessment | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: mHealth Risk Assessment | Intervention Type: OTHER; Name: mHealth Risk Assessment; Assigned to Arm(s): Control, Intervention
B: Arm Label: A, 1, I; Type: EXPERIMENTAL; Interventions: Device: Home blood pressure tele-management system. | Arm Label: A, 2, I; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care. | Intervention Type: DEVICE; Name: Home blood pressure tele-management system.; Assigned to Arm(s): A, 1, I | Intervention Type: OTHER; Name: Usual care.; Assigned to Arm(s): A, 2, I
C: Arm Label: Novel integrated care concept (NICC); Type: EXPERIMENTAL; Interventions: Other: Novel integrated care concept (NICC) | Arm Label: Standard care; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard care | Intervention Type: OTHER; Name: Novel integrated care concept (NICC); Assigned to Arm(s): Novel integrated care concept (NICC) | Intervention Type: OTHER; Name: Standard care; Assigned to Arm(s): Standard care
D: Arm Label: Intervention to Patients; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention to patients, Other: Usual care | Arm Label: Intervention to healthcare Professionals; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention to professionals, Other: Usual care | Arm Label: Mixed Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention to patients, Behavioral: Intervention to professionals, Other: Usual care | Arm Label: Control; Type: OTHER; Interventions: Other: Usual care | Intervention Type: BEHAVIORAL; Name: Intervention to patients; Assigned to Arm(s): Intervention to Patients, Mixed Intervention | Intervention Type: BEHAVIORAL; Name: Intervention to professionals; Assigned to Arm(s): Intervention to healthcare Professionals, Mixed Intervention | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Control, Intervention to Patients, Intervention to healthcare Professionals, Mixed Intervention

Answer: D