Effectiveness of a Diabetes Education Program based on Tailored interventions and Theory of Planned Behaviour: Cluster randomized controlled trial protocol

Abstract

Aim To measure the Effectiveness of a Diabetes Education Program for people with T2DM, based on Tailored interventions and the Theory of Planned Behaviour. Design Cluster randomized controlled clinical trial. Methods This multicentre study will be carried out at 30 primary healthcare centres, where 436 persons with Type 2 Diabetes Mellitus (T2DM), aged between 18–75 years, will be recruited. The experimental educational program to be applied is modelled using components obtained from a systematic review and prior qualitative analysis. In addition, a taxonomy of nursing practice is used to standardize the program, based on the Theory of Planned Behaviour as a conceptual model. The intervention will be carried out by community nurses, using ADAPP‐Ti®, an application developed with FileMaker Pro v.18. The control group will receive usual care and data will be collected at 6, 12, and 18 months, for both groups. The primary outcome considered will be glycosylated haemoglobin and cardiovascular factors, while the secondary ones will be tobacco consumption, body mass index, barriers to self‐care, health‐related quality of life, and lifestyle modification. The protocol was approved by the Ethics Committee of the Province of Malaga (Spain) in November 2014. Discussion The degree of metabolic control in T2DM is not always associated with healthy lifestyles and significant levels of medication are often prescribed to achieve clinical objectives. An intervention focused on needs, based on the best available evidence and a solid conceptual framework, might successfully consolidate appropriate self‐care behaviour in this population. Impact The study will result in the publication of an educational program featuring well‐defined interventions and activities that will enable clinicians to tailor health care to the individual's needs and to combat treatment inertia in attending this population.

Lasting effects of a brief, scalable diabetes conversation map psychosocial intervention on health beliefs and health behaviors: A large randomized controlled trial in Taiwan

“…duration of each session and number of sessions for each topic) and employing various behavior change theories, to assess the differential intervention effects on diet and exercise health behaviors of PWD. For example, a recently published protocol described a future RCT to evaluate the effectiveness of a diabetes education program based on the Theory of Planned Behavior (Caro‐Bautista et al, 2021).…”

Effectiveness of Tailored Care Program on Diabetes Self-Care Activity, Risk of Cardiovascular Disease and HbA1C among Patients with Diabetes in Indonesia: A Randomized Controlled Trial

“…Tailored care intervention can improve patients' adherence to treatment satisfaction and knowledge regardless of their clinical status, further improving self-care behavior or activity (Alfian et al, 2020;Cummings et al, 2019;Hu et al, 2016;Navodia et al, 2019;O'Neil et al, 2016). Other studies mention that tailored care through education and support programs effectively changes knowledge, attitudes, and medication-taking behaviors when compared to the non-provision of tailored care (Caro-Bautista et al, 2021;Choi et al, 2017;Cimo & Dewa, 2019b;Iovane et al, 2017). The main components of the implementation of tailored care intervention programs carried out by researchers consist of the implementation of brief deductive teaching or education and brainstorming with support groups.…”

Patient preferences in diabetes care: a bibliometric analysis

“…Information about any medication that does not require strict adherence to consumption is also desired by patients. This information will make patients pay more attention to information about foods they can and cannot consume (22,23). So far, patients are still not able to properly distinguish which foods are allowed and which foods they are not allowed to consume in certain quantities (24).…”