Periodic Reporting for period 2 - DIABFRAIL-LATAM (Scaling-up of and evidence-based intervention programme in older people with Diabetes and Frailty in LatinAmerica)
Période du rapport: 2020-07-01 au 2021-12-31
Diabetes is a high prevalence disorder in ageing populations (20% in people ≥ 65 yrs) with a chronic disease time-course and is associated with considerable medical co-morbidity, functional decrease and frailty, visual and lower limb disability, multiple medication usage and impaired quality of life and results in a high personal and social health burden, and a significant public health burden.
Stemming from the results of three EU-funded projects (MIDFRAIL, FRAILOMIC and VIVIFRAIL), DIABFRAIL-LATAM intends to make a scaling up of a multimodal intervention in older people with diabetes very vulnerable because of their frailty status. The project will take place in 4 Latin-American countries and the scaling up in different settings of care.
The primary outcome consists in the changes in function and quality of life as measured by changes in the scores used to assess them between baseline and 1-year follow-up. Function will be assessed by the Short Physical Performance Battery-SPPB.
This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status.
Diabfrail Latam initiative is original (never previously studied; both the intervention, the outcomes and the settings are unique for studies in diabetes), relevant (it addresses a topic of interest for around 30% of people with diabetes, that is the old frail and pre-frail people with diabetes), pertinent (it is focused on function, that is the main component of quality of life and the most important outcome in this population) and feasible (it will be carried out by senior researchers with previous relevant contributions in the fields of frailty and diabetes and its complications in older people). It will contribute to improve the quality of care in diabetic and frail patients and lees burden to health services
Stemming from the results of three EU-funded projects (MIDFRAIL, FRAILOMIC and VIVIFRAIL), DIABFRAIL-LATAM intends to make a scaling up of a multimodal intervention in older people with diabetes very vulnerable because of their frailty status. The project will take place in 4 Latin-American countries and the scaling up in different settings of care.
The primary outcome consists in the changes in function and quality of life as measured by changes in the scores used to assess them between baseline and 1-year follow-up. Function will be assessed by the Short Physical Performance Battery-SPPB.
This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status.
Diabfrail Latam initiative is original (never previously studied; both the intervention, the outcomes and the settings are unique for studies in diabetes), relevant (it addresses a topic of interest for around 30% of people with diabetes, that is the old frail and pre-frail people with diabetes), pertinent (it is focused on function, that is the main component of quality of life and the most important outcome in this population) and feasible (it will be carried out by senior researchers with previous relevant contributions in the fields of frailty and diabetes and its complications in older people). It will contribute to improve the quality of care in diabetic and frail patients and lees burden to health services
The project Scaling-up of and evidence-based intervention programme in older people with Diabetes and Frailty in LatinAmerica (DIABFRAIL-LATAM) is funded by the European Union's Horizon 2020 research and innovation programme.
During these first 18 months of the project, the Diabfrail Latam partners have undergone some significant challenges. The Diabfrail Latam study is progressing at a satisfactory pace, and significant achievements have been made during this period:
The intervention of the project has been designed. The exercise program, educational program and information sheets have been finished taking into account the different particularities in each participant country. All submissions to each involved Ethics committee have been done.
Kick off meeting took place in Madrid (H. Wellington) in January 24 and 25th 2020. A training meeting took place in November in Cartagena de Indias (14 and 15th) and Santiago de Chile (18 and 19th) In this training meeting, it was explained in detail the exercise program described in the study protocol and the data collection and the electronic case report form (eCRF).
All the necessary devices to start the recruitment (mainly the physical activity measure devices and dynamometers) have been acquired and sent to the different countries.
The site selection has already been completed in all involved countries (Peru, Colombia, Mexico and Chile).
A Clinical Research Organization (CRO) has been hired for all initial tasks until the activation of the different centers.
CRO is managing the submission of study documentation in all countries. The contracts are already signed, and the work is ongoing. The customization of essential documents into particularities in each country is completed and all documents have been submitted in all trial sites.
The Diabfrail Latam study is making good progress in all countries involved but current situation (COVID 19 pandemic) has slowed down the development of the study in all countries
During these first 18 months of the project, the Diabfrail Latam partners have undergone some significant challenges. The Diabfrail Latam study is progressing at a satisfactory pace, and significant achievements have been made during this period:
The intervention of the project has been designed. The exercise program, educational program and information sheets have been finished taking into account the different particularities in each participant country. All submissions to each involved Ethics committee have been done.
Kick off meeting took place in Madrid (H. Wellington) in January 24 and 25th 2020. A training meeting took place in November in Cartagena de Indias (14 and 15th) and Santiago de Chile (18 and 19th) In this training meeting, it was explained in detail the exercise program described in the study protocol and the data collection and the electronic case report form (eCRF).
All the necessary devices to start the recruitment (mainly the physical activity measure devices and dynamometers) have been acquired and sent to the different countries.
The site selection has already been completed in all involved countries (Peru, Colombia, Mexico and Chile).
A Clinical Research Organization (CRO) has been hired for all initial tasks until the activation of the different centers.
CRO is managing the submission of study documentation in all countries. The contracts are already signed, and the work is ongoing. The customization of essential documents into particularities in each country is completed and all documents have been submitted in all trial sites.
The Diabfrail Latam study is making good progress in all countries involved but current situation (COVID 19 pandemic) has slowed down the development of the study in all countries
In older patients with type 2 diabetes it is imperative to develop specific care plans, aimed to prevent and control for disability as the main target. The DIABFRAIL-LATAM project focuses on the use of interventions designed to improve functional status and enhance quality of life by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes
The EUROPE 2020 Strategy for smart, sustainable and inclusive growth states that “…important will be our ability to meet the challenge of promoting a healthy and active ageing population to allow for social cohesion and higher productivity”. This is the inspiration for DIABFRAIL-LATAM which seeks to match these goals and achieve this degree of impact.
Diabetes control is usually linked to the achievement of clinical targets, mainly those related to glycaemia and blood pressure levels. However, the standard targets for these two aspects of care have been challenged by the results from observational studies.
In addition, as our intervention is based on a comprehensive approach, we will expand the benefits of the control not only to the particular clinical targets, but also to other aspects of the disease, including functioning. This aim (increasing the percentage of patients with a good metabolic control according to the expanded criteria just explained) can be obtained in up to 47-72% of the participants allocated in the intervention branch, according to our own experience in MIDFRAIL. This means that in the general population of older people and taking into account the adherence to the programme and its feasibility, the improvement in the control of patients should reach the figure of 35-49%.
One of the main aims of this proposal is to scale-up an intervention that has shown to be effective but also efficient, based on the results of an economic analysis. This economic analysis has included not only an analysis of the healthcare costs and social care costs but also from the social perspective, showing in a very consistent way that intervention dominates control in the Incremental Cost-Effectiveness Ratio approach in all the domains explored.
Our intervention is multimodal in its approach, and centred on the needs of the patient; it is comprehensive as it embraces the main aspects of the disease (clinical targets, nutrition, avoiding hypoglycemia and physical exercise) which are related to the important outcome in older people (functional deterioration) and can be implemented in many settings, including those allocated in the community and in Primary Care – this will improve the responsiveness of the health services to the true needs of this vulnerable population.
The characteristics of the intervention, its feasibility, the local and regional barriers, the impact for the individuals in terms of function and quality of life, and the impact for the Health Systems and other societal benefits in terms of use of resources (hospitalizations, permanent institutionalizations, need of formal/informal care) and cost-effective value (assessed by an ICER approach) will be the main factors taken into account to make recommendations to the scaling-up, that is a fundamental part of our proposal
The EUROPE 2020 Strategy for smart, sustainable and inclusive growth states that “…important will be our ability to meet the challenge of promoting a healthy and active ageing population to allow for social cohesion and higher productivity”. This is the inspiration for DIABFRAIL-LATAM which seeks to match these goals and achieve this degree of impact.
Diabetes control is usually linked to the achievement of clinical targets, mainly those related to glycaemia and blood pressure levels. However, the standard targets for these two aspects of care have been challenged by the results from observational studies.
In addition, as our intervention is based on a comprehensive approach, we will expand the benefits of the control not only to the particular clinical targets, but also to other aspects of the disease, including functioning. This aim (increasing the percentage of patients with a good metabolic control according to the expanded criteria just explained) can be obtained in up to 47-72% of the participants allocated in the intervention branch, according to our own experience in MIDFRAIL. This means that in the general population of older people and taking into account the adherence to the programme and its feasibility, the improvement in the control of patients should reach the figure of 35-49%.
One of the main aims of this proposal is to scale-up an intervention that has shown to be effective but also efficient, based on the results of an economic analysis. This economic analysis has included not only an analysis of the healthcare costs and social care costs but also from the social perspective, showing in a very consistent way that intervention dominates control in the Incremental Cost-Effectiveness Ratio approach in all the domains explored.
Our intervention is multimodal in its approach, and centred on the needs of the patient; it is comprehensive as it embraces the main aspects of the disease (clinical targets, nutrition, avoiding hypoglycemia and physical exercise) which are related to the important outcome in older people (functional deterioration) and can be implemented in many settings, including those allocated in the community and in Primary Care – this will improve the responsiveness of the health services to the true needs of this vulnerable population.
The characteristics of the intervention, its feasibility, the local and regional barriers, the impact for the individuals in terms of function and quality of life, and the impact for the Health Systems and other societal benefits in terms of use of resources (hospitalizations, permanent institutionalizations, need of formal/informal care) and cost-effective value (assessed by an ICER approach) will be the main factors taken into account to make recommendations to the scaling-up, that is a fundamental part of our proposal