Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican

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.

Conditions

• Frailty Syndrome
• Frail Elderly Syndrome
• Diabetes Mellitus, Type 2

Interventions

OTHER

Multimodal intervention

1. Optimal control: HbA1c between 7.6-8.5% (60-69 mmol/mol) and Blood Pressure\<150/90 mmHg 2. The physical exercise program that will be used will be the Vivifrail program (Erasmus + UE). Vivifrail includes: Strength for arms and legs, balance and gait, flexibility and resistance. The duration will be 16 weeks. (3 weeks to explain the program in the Trial site and the rest of weeks, it will be carried out at home). 3. Nutritional and educational program 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 to maintain functional status. Seven separate sessions of 45 minutes each one twice a week for a period of 3-4 weeks in small groups. They will be moderated by a physician or diabetes educator and focused on behavioral changes and key points.

OTHER

Usual care group

The level of usual health care that a patient with diabetes receives from their local national health system

Sponsors & Collaborators

• Pan American Health Organization

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Diabetes Frail Ltd

  collaborator OTHER

• University of Castilla-La Mancha

  collaborator OTHER

• Confederación Española de Organizaciones de Mayores (CEOMA)

  collaborator UNKNOWN

• Pontificia Universidad Javeriana

  collaborator OTHER

• Pontificia Universidad Catolica de Chile

  collaborator OTHER

• Instituto Nacional de Geriatria, Mexico

  collaborator OTHER_GOV

• Universidad de San Martín de Porres (USMP)

  collaborator UNKNOWN

• Universidad de Santiago de Chile

  collaborator OTHER

• Consorcio Centro de Investigación Biomédica en Red (CIBER)

  lead OTHER_GOV

Principal Investigators

• LEOCADIO RODRIGUEZ-MAÑAS, PhD · Consorcio Centro de Investigación Biomédica en Red (CIBER)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-14

Primary Completion

2024-04-30

Completion

2024-05-31

Countries

• Colombia

Study Locations