Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05719675 |
| Other study ID # |
522006894 |
| Secondary ID |
CE/FESI/052022/1 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
May 17, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Universidad Nacional Autonoma de Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Type 2 Diabetes Mellitus (T2DM) is a group of metabolic disorders characterized by
hyperglycemia in the absence of treatment, positioned in the first places of prevalence and
mortality in the Mexican population. Adherence to treatment is a central element to prevent
complications of the disease, where the active participation of the patient in his or her
treatment is fundamental. Despite institutional healthcare efforts to promote this element,
there is no clarity in the Clinical Practice Guidelines aimed at the attention of people with
T2DM on how to achieve it.
The aim of this project will be to evaluate the effect of an intervention based on
Contingency Behavior Analysis on treatment adherence, quality of life and glycemic level in
people with newly diagnosed T2DM.
Pre-experimental design with pretest and posttest measurements. The Dependent Variable will
be an intervention based on Contingency Behavior Analysis.
The Independent Variables will be adherence to treatment, quality of life and glycemic level.
The power calculation suggests an n = 38, using sequential non-probability sampling.
People older than 18 years with less than 5 years of T2DM diagnosis will be included.
Pretest and posttest differences, effect size and correlations between measurement variables
will be analyzed.
It is expected that the intervention based on Contingency Behavior Analysis will encourage
the active participation of people with T2DM, improving their adherence to treatment,
glycemic level and quality of life.
Considering that the Clinical Practice Guidelines emphasize the importance of therapeutic
adherence through the active participation of the patient and his/her environment, it is
expected that this project will provide the tools for behavioral change that so far are not
included in public health in Mexico.
Description:
Currently, Type 2 Diabetes Mellitus (T2DM) in Mexico is the third leading cause of mortality
in men and the second leading cause in women. Furthermore, due to the inadequate management
of T2DM during the Covid-19 pandemic, an excess mortality of 35.6% was observed in the
January-August 2020 period. The impact of the disease on people's health is also reflected in
morbidity through diabetic complications and comorbidities related to T2DM such as
cardiovascular diseases, dyslipidemias, overweight and obesity. In the case of diabetic
comorbidities and complications it must be considered that sometimes they are not really due
to inadequate self-care on the part of the patient, but are part of the natural progression
of the disease as each person ages. However, whether the origin of diabetic complications is
due to the patient's inadequate self-care behaviors or to the natural progression of the
disease, the person with T2DM needs to receive comprehensive guidance to cope with disease
conditions, treatment and self-care through prevention strategies and diabetes education.
In this regard, over the last decade, the Mexican health system has made various efforts to
address this issue. Either through national health care programs at the federal and state
levels, or through the implementation of mexican Clinical Practice Guidelines (mCPG) for the
management of patients with T2DM. However, despite these implementations, in a period of 9
years (2011-2020) an increase in the registered death rate due to T2DM has been observed from
7.0 per ten thousand inhabitants in 2011 to 8.2 in 2020, which suggests that a change in the
practice of care directed to this population is necessary. Perhaps one of the main problems
that prevents a change in practice is the belief that it is enough to simply provide people
with information on health care so that they are able to implement it in their daily lives.
However, for years it has been pointed out and demonstrated that this was not enough, but
that it was also necessary to provide people with the appropriate strategies for the
development of new care behaviors. To achieve this, the Latin American Diabetes Association
has recommended that programs encourage the active participation of people with T2DM, a
recommendation that is even reflected in some health programs in Mexico . This leads to the
second problem that is hindering the development of true health care that fosters the active
participation of its users: professional training. In Mexico, the psychology professional is
considered as a healthcare provider only on the rehabilitation of the adult lower extremity
amputee patient due to T2DM, in the follow-up of physical exercise prescription, as part of
nursing interventions for the control of T2DM in adult population, and in the prevention and
diagnosis of T2DM in pediatric patients. This occurs despite the fact that most programs and
mCPGs emphasize the importance of psychological assessment and intervention for the
modification of risk behaviors and the development of healthy habits. However, by not
considering psychology professionals formally to carry out education strategies, these tasks
are relegated to other professionals such as physicians, nurses, nutritionists and social
workers who, although they have the training to provide information about diabetes, do not
have adequate training to promote the necessary behavioral modification in the development of
healthy habits and promote the active participation of patients with T2DM in the search for
solutions to contextual barriers, promoting health care in their daily lives through
deprofessionalization work.
It would be expected that this intervention model, by improving the TA of people with Type 2
Diabetes Mellitus, would improve the participants' evaluation of their quality of life in
areas such as diabetes control, anxiety related to the disease, social burden, sexual
function and energy, as well as in glycemic level, mainly. In addition, this type of
intervention proposals can offer a double benefit in terms of Effectiveness by modifying
those situational aspects that hinder an adequate adherence to treatment in people with T2DM;
and in terms of Efficiency, by allowing to carry out a work where participants can be trained
as health promoters, and thus increase the dissemination of health services through the
mediation of participants in the sectors close to them and that, due to institutional
limitations, this population does not have direct access to them.
