<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04504968</url>
  </required_header>
  <id_info>
    <org_study_id>DIABFRAIL-LATAM</org_study_id>
    <nct_id>NCT04504968</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican</brief_title>
  <acronym>DIABFRAIL</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consorcio Centro de Investigación Biomédica en Red (CIBER)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pan American Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Diabetes Frail Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Confederación Española de Organizaciones de Mayores (CEOMA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontificia Universidad Javeriana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pontificia Universidad Catolica de Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Nacional de Geriatria, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de San Martín de Porres (USMP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad de Santiago de Chile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Consorcio Centro de Investigación Biomédica en Red (CIBER)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized clinical trial, international, multicentre, single-blind, two parallel groups,&#xD;
      pragmatic. It will be carried out by investigators in several Latin American countries&#xD;
      (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to&#xD;
      Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5 trial sites&#xD;
      that will recruit 0-60 participants. Finally, 1050 subjects will be involved in the project.&#xD;
&#xD;
      The primary outcome are the changes in function and quality of life as measured by changes in&#xD;
      the scores used to assess them between baseline and 1-year follow-up. Function will be&#xD;
      assessed by the Short Physical Performance Battery-SPPB.&#xD;
&#xD;
      This study is focused on an older population (≥ 65 years) with diabetes and a frail or&#xD;
      prefrail status&#xD;
&#xD;
      The intervention includes:&#xD;
&#xD;
      Educational program in small groups: 7 sessions in the clinical trial sites (2 sessions a&#xD;
      week for the first 3-4 weeks) Exercise program (16 weeks): learning phases in clinical trial&#xD;
      site for 3-4 first week (coincident with the educational program sessions) and the rest at&#xD;
      home.&#xD;
&#xD;
      Adaptation of targets of HbA1c and blood pressure (BP). UCG Usual care group consists in&#xD;
      level of care usually given in Health Care system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      International, multicentre, single-blind, two parallel groups, pragmatic randomised Research&#xD;
      Clinical Trial. It will be carried out by investigators in several Latin American countries&#xD;
      (Chile, Colombia, Mexico and Peru) and with random allocation 1:1 of the participants to&#xD;
      Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5-7 trial sites&#xD;
      that will recruit 51 participants (255 participants per country) except Mexico which will&#xD;
      select 2 sites to recruit 50 participants each one (100 participants).&#xD;
&#xD;
      There will be a National lead investigator in each involved country. This National lead&#xD;
      investigator will be trained by the general coordinator team in the procedures of the study.&#xD;
      Each National lead investigator will be responsible for the training in his/her country. In&#xD;
      each country, the lead will select the recruitment trial sites (5-7 in each country) and each&#xD;
      trial site will recruit 51 participants approximately except in Mexico (see above). All data&#xD;
      will be collected in an eCRF (electronic case report form) platform designed specifically for&#xD;
      this project.&#xD;
&#xD;
      This study is focused on an older population (≥ 65 years) with diabetes and a frail or&#xD;
      prefrail status.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Main objective: To assess the effectiveness of a multi-modal intervention in subjects with&#xD;
      type 2 Diabetes Mellitus aged ≥ 65 years who are frail or pre-frail in terms of function and&#xD;
      quality of life in comparison with usual clinical practice.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Changes in the frailty status (trajectories of frailty: frail to prefrail; frail to&#xD;
           robustness; prefrail to robustness and vice versa).&#xD;
&#xD;
        -  Incidence rate of symptomatic hypoglycemia and hypoglycemic coma.&#xD;
&#xD;
        -  Incidence rate of hospital admission.&#xD;
&#xD;
        -  Incidence rate of permanent institutionalization.&#xD;
&#xD;
        -  Carer burden.&#xD;
&#xD;
        -  Laboratory biomarkers of prognostic value for response to treatment&#xD;
&#xD;
      Usual care group:&#xD;
&#xD;
      Usual clinical practice is the level of usual health care that a patient with diabetes&#xD;
      receives from their local national health system.&#xD;
&#xD;
      Intervention group:&#xD;
&#xD;
        1. Optimal glycosylated hemoglobin range between 7.6-8.5% (60-69 mmol/mol) and optimal&#xD;
           blood pressure: &lt;150/90 mmHg&#xD;
&#xD;
        2. Physical exercise program that will be used will be the Vivifrail program, developed in&#xD;
           Europe (Erasmus + UE). Vivifrail includes:&#xD;
&#xD;
             -  Strength exercises for arms and legs.&#xD;
&#xD;
             -  Balance and gait, to avoid falls.&#xD;
&#xD;
             -  Flexibility.&#xD;
&#xD;
             -  Resistance. The duration of the training program will be 16 weeks.&#xD;
&#xD;
        3. Nutritional and educational program: The intervention is designed to increase diabetes&#xD;
           knowledge, develop practical self-care skills for diabetes, and increase the likelihood&#xD;
           of improving glycemic control safely. The intervention aims to minimize the risk of&#xD;
           hypoglycemia, ensure optimal nutritional status, and help maintain functional status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 14, 2022</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in physical function</measure>
    <time_frame>1 year</time_frame>
    <description>(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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frailty trajectories</measure>
    <time_frame>1 year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty trajectories</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty trajectories</measure>
    <time_frame>1 year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic activities of daily living</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental activities of daily living</measure>
    <time_frame>1 year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Hypoglycemia</measure>
    <time_frame>1 year</time_frame>
    <description>Episodes of symptomatic hypoglycemia (proven glycaemia below 4mmol/L, or signs and symptoms attributed to hypoglycemia that respond to specific treatment) and hypoglycemic coma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital admission</measure>
    <time_frame>1 year</time_frame>
    <description>Episodes of hospital admission (any overnight admission)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Permanent institutionalization</measure>
    <time_frame>1 year</time_frame>
    <description>Permanent Institutionalization yeas or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Falls</measure>
    <time_frame>1 year</time_frame>
    <description>Number of falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Severe Falls</measure>
    <time_frame>1 year</time_frame>
    <description>Number of severe falls (2 or more falls in the year or at least 1 fall that requires medical assistance)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver burden</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients who died</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">713</enrollment>
  <condition>Frailty Syndrome</condition>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multimodal intervention:</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual care group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimodal intervention</intervention_name>
    <description>Optimal control: HbA1c between 7.6-8.5% (60-69 mmol/mol) and Blood Pressure&lt;150/90 mmHg&#xD;
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).&#xD;
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.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care group</intervention_name>
    <description>The level of usual health care that a patient with diabetes receives from their local national health system</description>
    <arm_group_label>Usual care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged ≥ 65 years.&#xD;
&#xD;
          -  The subject is willing and able to give written informed consent for participation in&#xD;
             the study.&#xD;
&#xD;
          -  Diagnosis of type 2 diabetes for at least 2 years&#xD;
&#xD;
          -  Require to fulfill Fried´s criteria for frail or pre-frail individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent or accept randomization to either&#xD;
             study group&#xD;
&#xD;
          -  Plans to relocate out of the study area within the year or plans to be out of the&#xD;
             study area for more than 6 consecutive weeks in the next year&#xD;
&#xD;
          -  MoCA (Montreal Cognitive Assessment) lower than 17/30&#xD;
&#xD;
          -  Cancer requiring treatment in the past 3 years,except for non-melanoma skin cancers or&#xD;
             cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer)&#xD;
&#xD;
          -  Barthel ADL score lower than 60 points&#xD;
&#xD;
          -  Inability to carry out the SPPB test (total score = 0)&#xD;
&#xD;
          -  Upper and/or lower extremity amputation&#xD;
&#xD;
          -  Current participation in a structured physical activity (PA) program, physical therapy&#xD;
             or cardiopulmonary rehabilitation&#xD;
&#xD;
          -  Current enrolment in another randomized clinical trial (RCT) involving lifestyle,&#xD;
             nutrition, or pharmaceutical interventions&#xD;
&#xD;
          -  Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             investigator may interfere with the study participation&#xD;
&#xD;
          -  Other illness of such severity that life expectancy is expected to be less than 12&#xD;
             months&#xD;
&#xD;
          -  Any other condition that is an absolute contraindication to the exercise program:&#xD;
&#xD;
          -  Acute heart attack (recent 3-6 months) or unstable angina&#xD;
&#xD;
          -  Uncontrolled atrial or ventricular arrhythmias&#xD;
&#xD;
          -  Aortic dissecting aneurysm&#xD;
&#xD;
          -  Severe aortic stenosis&#xD;
&#xD;
          -  Acute endocarditis / pericarditis&#xD;
&#xD;
          -  Uncontrolled high blood pressure (&gt; 180/100 mmHg)&#xD;
&#xD;
          -  Acute thromboembolism&#xD;
&#xD;
          -  Acute or severe heart failure&#xD;
&#xD;
          -  Acute or severe respiratory failure&#xD;
&#xD;
          -  Uncontrolled postural hypotension&#xD;
&#xD;
          -  Uncontrolled acute decompensated diabetes mellitus or low blood sugar&#xD;
&#xD;
          -  A recent fracture in the last month Any other circumstance the investigator believes&#xD;
             to prevent undertaking physical activity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LEOCADIO RODRIGUEZ-MAÑAS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consorcio Centro de Investigación Biomédica en Red (CIBER)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital San Ignacio_Universidad Javeriana</name>
      <address>
        <city>Bogotá</city>
        <zip>11001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04504968
org study id: DIABFRAIL-LATAM
nct id: NCT04504968
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Difference in physical function
time frame: 1 year
description: (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.
measure: Frailty trajectories
time frame: 1 year
description: 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
measure: Frailty trajectories
time frame: 1 year
description: 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.
measure: Frailty trajectories
time frame: 1 year
description: 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
measure: Basic activities of daily living
time frame: 1 year
description: 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.
measure: Instrumental activities of daily living
time frame: 1 year
description: 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
measure: Rate of Hypoglycemia
time frame: 1 year
description: Episodes of symptomatic hypoglycemia (proven glycaemia below 4mmol/L, or signs and symptoms attributed to hypoglycemia that respond to specific treatment) and hypoglycemic coma
measure: Number of Hospital admission
time frame: 1 year
description: Episodes of hospital admission (any overnight admission)
measure: Number of patients with Permanent institutionalization
time frame: 1 year
description: Permanent Institutionalization yeas or not
measure: Rate of Falls
time frame: 1 year
description: Number of falls
measure: Rate of Severe Falls
time frame: 1 year
description: Number of severe falls (2 or more falls in the year or at least 1 fall that requires medical assistance)
measure: Caregiver burden
time frame: 1 year
description: 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.
measure: Rate of mortality
time frame: 1 year
description: Number of patients who died
measure: Health-related quality of life
time frame: 1 year
description: 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.
arm group label: Intervention group
arm group type: Experimental
description: Multimodal intervention:
arm group label: Usual care group
arm group type: Placebo Comparator
description: Usual care group
intervention type: Other
intervention name: Multimodal intervention
description: 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.
arm group label: Intervention group
intervention type: Other
intervention name: Usual care group
description: The level of usual health care that a patient with diabetes receives from their local national health system
arm group label: Usual care group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: LEOCADIO RODRIGUEZ-MAÑAS, PhD
role: Principal Investigator
affiliation: Consorcio Centro de Investigación Biomédica en Red (CIBER)
facility: 
country: Colombia
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Syndrome
mesh term: Frailty
sharing ipd: No