Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial

Yolanda Ramallo-Fariña, Amado Rivero-Santana, Lidia García-Pérez, Miguel Angel García-Bello, Ana Maria Wägner, Himar Gonzalez-Pacheco, Leticia Rodríguez-Rodríguez, Sybille Kaiser-Girardot, Guillermo Monzón-Monzón, Carolina Guerra-Marrero, Carmen Daranas-Aguilar, Margarita Roldán-Ruano, Montserrat Carmona, Pedro G Serrano-Aguilar, INDICA Team, Abraham Pérez de la Rosa, Alicia Pareja Ríos, Andrés Sifre Perello, Ángela Trinidad Gutiérrez Pérez, Antonio Cabrera de León, Antonio García Quintana, Armando Carrillo Domínguez, Bernardo Eusebio Herrera Domínguez, Carlos Sedeño Pérez, Carlos Ramírez Álamo, Cecilia Lobos Soto, Cristina Padrón Pérez, Dácil Alvarado Martel, Daniel Hernández Obregón, Dulce N Hernández Correa, Elsa Espinosa Pozuelo, Elsa Florido Mayor, Engracia Pinilla Domínguez, Fátima Herrera García, Félix Bonilla Aguiar, Francisco Cabrera López, Gloria Guerra de la Torre, Gregorio Muelas Martín, Héctor Dela Rosa Merino, Ignacio García Puente, Ignacio Llorente Gómez de Segura, Isabel García Calcerrada, Jacqueline Álvarez Pérez, Jorge Federico Aldunate Page, Jose Antonio García Dopico, Juan Andrés Báez Hernández, Juan José Pérez Valencia, Julia Charlotte Wiebe, Lilisbeth Perestelo Pérez, Leopoldo Martín Martín, Luis Morcillo Herrera, Marcos Estupiñán Ramírez, María Inmaculada González Pérez, María Isabel Visuerte Morales, María Pino Afonso Medina, Marta Riaño Ruiz, Marta Tejera Santana, Mauro Boronat, Mercedes Lorenzo Medina, Miguel Juan Mora García, Nayra Pérez Delgado, Pablo Pedrianez Martín, Pedro de Pablos-Velasco, Pilar Peláez Alba, Rafael Valcárcel, Remedios Castro Sánchez, Rodrigo Abreu González, Rosa Borges Trujillo, Víctor Lorenzo Sellarés, Yolanda Ramallo-Fariña, Amado Rivero-Santana, Lidia García-Pérez, Miguel Angel García-Bello, Ana Maria Wägner, Himar Gonzalez-Pacheco, Leticia Rodríguez-Rodríguez, Sybille Kaiser-Girardot, Guillermo Monzón-Monzón, Carolina Guerra-Marrero, Carmen Daranas-Aguilar, Margarita Roldán-Ruano, Montserrat Carmona, Pedro G Serrano-Aguilar, INDICA Team, Abraham Pérez de la Rosa, Alicia Pareja Ríos, Andrés Sifre Perello, Ángela Trinidad Gutiérrez Pérez, Antonio Cabrera de León, Antonio García Quintana, Armando Carrillo Domínguez, Bernardo Eusebio Herrera Domínguez, Carlos Sedeño Pérez, Carlos Ramírez Álamo, Cecilia Lobos Soto, Cristina Padrón Pérez, Dácil Alvarado Martel, Daniel Hernández Obregón, Dulce N Hernández Correa, Elsa Espinosa Pozuelo, Elsa Florido Mayor, Engracia Pinilla Domínguez, Fátima Herrera García, Félix Bonilla Aguiar, Francisco Cabrera López, Gloria Guerra de la Torre, Gregorio Muelas Martín, Héctor Dela Rosa Merino, Ignacio García Puente, Ignacio Llorente Gómez de Segura, Isabel García Calcerrada, Jacqueline Álvarez Pérez, Jorge Federico Aldunate Page, Jose Antonio García Dopico, Juan Andrés Báez Hernández, Juan José Pérez Valencia, Julia Charlotte Wiebe, Lilisbeth Perestelo Pérez, Leopoldo Martín Martín, Luis Morcillo Herrera, Marcos Estupiñán Ramírez, María Inmaculada González Pérez, María Isabel Visuerte Morales, María Pino Afonso Medina, Marta Riaño Ruiz, Marta Tejera Santana, Mauro Boronat, Mercedes Lorenzo Medina, Miguel Juan Mora García, Nayra Pérez Delgado, Pablo Pedrianez Martín, Pedro de Pablos-Velasco, Pilar Peláez Alba, Rafael Valcárcel, Remedios Castro Sánchez, Rodrigo Abreu González, Rosa Borges Trujillo, Víctor Lorenzo Sellarés

Abstract

Objective: This study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term. Design: open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions.

Participants: A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres.

Setting: Primary Care Centers in Canary Islands (Spain).

Intervention: The intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI).

Outcome measure: Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables.

Results: Compared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).

Conclusions: Assessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits.

Trial registration number: ClinicalTrials.gov NCT01657227 (6 August 2012) https://ichgcp.net/clinical-trials-registry/NCT01657227.

Keywords: diabetes & endocrinology; health informatics; primary care; quality in health care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials flow diagram. ADDQoL, Audit of Diabetes-Dependent Quality of life; BDI-II, Beck Depression Inventory II; CBI, combined intervention for patients and professionals; DDS2, Diabetes Distress Scale; DES-SF, Diabetes Empowerment Scale-Short Form; MEDAS, Mediterranean Diet Adherence Screener; MGLS, Morisky Medication Adherence Scale; MNSI, Michigan Neuropathy Screening Instrument; PFI, intervention for professionals; PHCP, Primary Care Health Practices; PTI, intervention for patients; STAI-S, State Trait Anxiety Inventory.

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