Clinical trial NCT04504968: Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican
Official title: Randomized Clinical Trial to Evaluate the Effectiveness of a Multimodal Intervention Program in Prefrail and Frail Type 2 Diabetic Patients on Frailty and Quality of Life in Latinamerican Countries
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frailty Syndrome
Frail Elderly Syndrome
Diabetes Mellitus, Type 2
Lead sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Sponsor class: OTHER_GOV
Collaborators: name: Pan American Health Organization
name: Catholic University of the Sacred Heart
name: Diabetes Frail Ltd
name: University of Castilla-La Mancha
name: Confederación Española de Organizaciones de Mayores (CEOMA)
name: Pontificia Universidad Javeriana
name: Pontificia Universidad Catolica de Chile
name: Instituto Nacional de Geriatria, Mexico
name: Universidad de San Martín de Porres (USMP)
name: Universidad de Santiago de Chile
First posted: 2020-08-07
Enrollment: 713
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: he DIABFRAIL-LATAM is an open randomized clinical trial, with random allocation 1:1 by participants to Usual Care Group (UCG) or Intervention Group (IG)
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial, international, multicentre, single-blind, two parallel groups, pragmatic. It will be carried out by investigators in several Latin American countries (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5 trial sites that will recruit 0-60 participants. Finally, 1050 subjects will be involved in the project.

The primary outcome are 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

The intervention includes:

Educational program in small groups: 7 sessions in the clinical trial sites (2 sessions a week for the first 3-4 weeks) Exercise program (16 weeks): learning phases in clinical trial site for 3-4 first week (coincident with the educational program sessions) and the rest at home.

Adaptation of targets of HbA1c and blood pressure (BP). UCG Usual care group consists in level of care usually given in Health Care system.

Detailed description: International, multicentre, single-blind, two parallel groups, pragmatic randomised Research Clinical Trial. It will be carried out by investigators in several Latin American countries (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5-7 trial sites that will recruit 51 participants (255 participants per country) except Mexico which will select 2 sites to recruit 50 participants each one (100 participants).

There will be a National lead investigator in each involved country. This National lead investigator will be trained by the general coordinator team in the procedures of the study. Each National lead investigator will be responsible for the training in his/her country. In each country, the lead will select the recruitment trial sites (5-7 in each country) and each trial site will recruit 51 participants approximately except in Mexico (see above). All data will be collected in an eCRF (electronic case report form) platform designed specifically for this project.

This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status.

Objectives:

Main objective: To assess the effectiveness of a multi-modal intervention in subjects with type 2 Diabetes Mellitus aged ≥ 65 years who are frail or pre-frail in terms of function and quality of life in comparison with usual clinical practice.

Secondary objectives:

* Changes in the frailty status (trajectories of frailty: frail to prefrail; frail to robustness; prefrail to robustness and vice versa).
* Incidence rate of symptomatic hypoglycemia and hypoglycemic coma.
* Incidence rate of hospital admission.
* Incidence rate of permanent institutionalization.
* Carer burden.
* Laboratory biomarkers of prognostic value for response to treatment

Usual care group:

Usual clinical practice is the level of usual health care that a patient with diabetes receives from their local national health system.

Intervention group:

1. Optimal glycosylated hemoglobin range between 7.6-8.5% (60-69 mmol/mol) and optimal blood pressure: \<150/90 mmHg
2. Physical exercise program that will be used will be the Vivifrail program, developed in Europe (Erasmus + UE). Vivifrail includes:

   * Strength exercises for arms and legs.
   * Balance and gait, to avoid falls.
   * Flexibility.
   * Resistance. The duration of the training program will be 16 weeks.
3. Nutritional and educational program: The intervention is designed to increase diabetes knowledge, develop practical self-care skills for diabetes, and increase the likelihood of improving glycemic control safely. The intervention aims to minimize the risk of hypoglycemia, ensure optimal nutritional status, and help maintain functional status.

Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥ 65 years.
* The subject is willing and able to give written informed consent for participation in the study.
* Diagnosis of type 2 diabetes for at least 2 years
* Require to fulfill Fried´s criteria for frail or pre-frail individuals

Exclusion Criteria:

* Unable or unwilling to provide informed consent or accept randomization to either study group
* Plans to relocate out of the study area within the year or plans to be out of the study area for more than 6 consecutive weeks in the next year
* MoCA (Montreal Cognitive Assessment) lower than 17/30
* Cancer requiring treatment in the past 3 years,except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer)
* Barthel ADL score lower than 60 points
* Inability to carry out the SPPB test (total score = 0)
* Upper and/or lower extremity amputation
* Current participation in a structured physical activity (PA) program, physical therapy or cardiopulmonary rehabilitation
* Current enrolment in another randomized clinical trial (RCT) involving lifestyle, nutrition, or pharmaceutical interventions
* Other medical, psychiatric, or behavioral factors that in the judgment of the investigator may interfere with the study participation
* Other illness of such severity that life expectancy is expected to be less than 12 months
* Any other condition that is an absolute contraindication to the exercise program:
* Acute heart attack (recent 3-6 months) or unstable angina
* Uncontrolled atrial or ventricular arrhythmias
* Aortic dissecting aneurysm
* Severe aortic stenosis
* Acute endocarditis / pericarditis
* Uncontrolled high blood pressure (\> 180/100 mmHg)
* Acute thromboembolism
* Acute or severe heart failure
* Acute or severe respiratory failure
* Uncontrolled postural hypotension
* Uncontrolled acute decompensated diabetes mellitus or low blood sugar
* A recent fracture in the last month Any other circumstance the investigator believes to prevent undertaking physical activity

Primary outcomes:
measure: Difference in physical function
timeFrame: 1 year
Secondary outcomes:
measure: Frailty trajectories
timeFrame: 1 year
measure: Frailty trajectories
timeFrame: 1 year
measure: Frailty trajectories
timeFrame: 1 year
measure: Basic activities of daily living
timeFrame: 1 year
measure: Instrumental activities of daily living
timeFrame: 1 year
measure: Rate of Hypoglycemia
timeFrame: 1 year
measure: Number of Hospital admission
timeFrame: 1 year
measure: Number of patients with Permanent institutionalization
timeFrame: 1 year
measure: Rate of Falls
timeFrame: 1 year
measure: Rate of Severe Falls
timeFrame: 1 year
measure: Caregiver burden
timeFrame: 1 year
measure: Rate of mortality
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital San Ignacio_Universidad Javeriana
Study officials:
affiliation: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: LEOCADIO RODRIGUEZ-MAÑAS, PhD
role: PRINCIPAL_INVESTIGATOR
References: