Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Lat… (NCT04504968) | Clinical Trial Compass
UnknownNot Applicable
Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican
Colombia713 participantsStarted 2022-02-14
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in physical function
Timeframe: 1 year
Trial details
NCT IDNCT04504968
SponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)