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

NCT04504968 | Unknown DMC

• 1 other identifier: DIABFRAIL-LATAM
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Difference in physical function

  (SPPB scale)The primary outcome is the difference in function after 12 months of follow-up between the intervention group and usual clinical practice measured by changes in the Short Physical Performance Battery (SPPB) scale. SPPB scores between 0-12. 0 is the worse and 12 the best value.

  1 year

Secondary Outcomes (13)

• Frailty trajectories

  1 year

• Frailty trajectories

  1 year

• Frailty trajectories

  1 year

• Basic activities of daily living

  1 year

• Instrumental activities of daily living

  1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

Multimodal intervention:

Other: Multimodal intervention

Usual care group

PLACEBO COMPARATOR

Usual care group

Other: Usual care group

Interventions

Multimodal intervention OTHER

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.

Intervention group

Usual care group OTHER

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

Usual care group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Pan American Health Organization: collaborator
• Catholic University of the Sacred Heart: collaborator
• Diabetes Frail Ltd: collaborator
• University of Castilla-La Mancha: collaborator
• Confederación Española de Organizaciones de Mayores (CEOMA): collaborator
• Pontificia Universidad Javeriana: collaborator
• Pontificia Universidad Catolica de Chile: collaborator
• Instituto Nacional de Geriatria, Mexico: collaborator
• Universidad de San Martín de Porres (USMP): collaborator
• Universidad de Santiago de Chile: collaborator

Study Sites (1)

Hospital San Ignacio_Universidad Javeriana

Bogotá, 11001, Colombia

Location

MeSH Terms

Conditions

Frailty; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• LEOCADIO RODRIGUEZ-MAÑAS, PhD

  Consorcio Centro de Investigación Biomédica en Red (CIBER)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: August 7, 2020
• Study Start: February 14, 2022
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)