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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2; Frail Elderly Syndrome; Frailty Syndrome
• Intervention / Treatment: Other: Multimodal intervention; Other: Usual care group

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.

• Study Type: Interventional
• Enrollment (Estimated): 713
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: OLGA LAOSA, PhD; Phone Number: 2689 0034 916839360; Email: olga.laosa@salud.madrid.org
• Study Contact Backup: Name: LEOCADIO RODRIGUEZ-MAÑAS, PhD; Phone Number: 2689 0034 916839360; Email: leocadio.rodriguez@salud.madrid.org

Study Locations

• Colombia
  • Bogotá, Colombia, 11001
    • Hospital San Ignacio_Universidad Javeriana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Multimodal intervention:	Other: Multimodal intervention; Optimal control: HbA1c between 7.6-8.5% (60-69 mmol/mol) and Blood Pressure<150/90 mmHg; 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).; 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.
Placebo Comparator: Usual care group	Other: Usual care group; The level of usual health care that a patient with diabetes receives from their local national health system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty trajectories	Trajectories of frailty according to changes in Fried´s phenotype. Frieds Phenotype scores between 0 and 5. 0 means robust; 1-2 mean prefrail and 3 or more mean frail	1 year
Frailty trajectories	Trajectories of frailty according to changes frail trait scale (FTS). FTS scores between 0-50. 0 is the best value and 50 the worst value.	1 year
Frailty trajectories	Trajectories of frailty according to changes in FRAIL scale. FRAIL scores SPPB scores between 0-5. 0 means robust; 1-2 mean prefrail and 3 or more mean frail	1 year
Basic activities of daily living	Deterioration of basic activities of daily living (BADL) according to changes in at least 10 points of Barthel index. Barthel scores between 0-100; 0 is the worst value and 100 the best.	1 year
Instrumental activities of daily living	Deterioration of instrumental activities of daily living (IADL) according to changes in at least 1 point of Lawton scale. Lawton scale scores between 0-10; 0 is the worst and 10 the best value	1 year
Rate of Hypoglycemia	Episodes of symptomatic hypoglycemia (proven glycaemia below 4mmol/L, or signs and symptoms attributed to hypoglycemia that respond to specific treatment) and hypoglycemic coma	1 year
Number of Hospital admission	Episodes of hospital admission (any overnight admission)	1 year
Number of patients with Permanent institutionalization	Permanent Institutionalization yeas or not	1 year
Rate of Falls	Number of falls	1 year
Rate of Severe Falls	Number of severe falls (2 or more falls in the year or at least 1 fall that requires medical assistance)	1 year
Caregiver burden	Caregiver burden (if exist) evaluated by the Zarit scale (ZBI). The ZBI consists of 22 items rated that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88.9 Higher scores indicate greater burden.	1 year
Rate of mortality	Number of patients who died	1 year
Health-related quality of life	Changes in Participant Health-related quality of life evaluated by EuroQoL 5D 3L(European Quality of life). EuroQoL scores between 0-10 and 10 is the worse quality of life.	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome; Frailty
• Other Study ID Numbers: DIABFRAIL-LATAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No