Clinical trial NCT04491253: Social Support Intervention for Self-management of Type 2 Diabetes Mellitus
Official title: Efficacy of a Social Support Intervention in Adults for Self-management of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Nursing Outcomes Classification Terminology
Self-management
Social support
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of a social support intervention for self-management of type 2 diabetes mellitus (DM2) in adults. This intervention is based on a medium-range nursing theory of individual and family self-management. Findings will be evaluated using the nursing outcomes "self-management: diabetes" and "social support" from the Nursing Outcomes Classification (NOC).

Detailed description: Diabetes mellitus is responsible for 1.6 million deaths a year, becoming one of the world's 21st century health emergencies.

DM2 is the most frequent form of diabetes, accounting for 90% of all cases of this chronic condition. If this trend continues, by 2045 about 693 million people will have diabetes.

People with chronic diseases have changing perspectives, in addition to suffering physical alterations, their psychological, emotional and social state is also compromised, presenting themselves as a need to modify lifestyle to improve prognosis, facing alterations in the ability to socialize and with death or a great loss. Few studies comprehensively address these dimensions.

The literature reports that DM2 self-control has a direct effect in improving clinical results, reducing complications and quality of life. Therefore, the patient must make multiple decisions every day regarding diet, physical activity, glucose control, and medication compliance.

However, intervention studies that seek to improve self-management behaviors in people with DM2 are characterized by emphasizing the transmission of knowledge and establishing compliance with prescribed treatments, but they do not address social and emotional elements such as social support. Additionally, most of these interventions do not show the use of theoretical models that provide explanations of human responses to disease and other phenomena important to practice.

Studies using the Nursing Outcomes Classification to assess the effect of social support interventions are scarce.

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years with a diagnosis of DM2, attending the outpatient diabetes consultation at the health care institution.
* Initial score less than or equal to 3 on the NOC outcomes: self-management: diabetes and social support.

Exclusion Criteria:

* People with a score \<30 on the cognitive mini mental test.
* Other comorbidities reported by the patient or in the medical history that limit receiving the intervention (example: hearing loss, deafness, Alzheimer's disease).

Primary outcomes:
measure: Self-management: diabetes
timeFrame: 2 months
Secondary outcomes:
measure: Social support
timeFrame: 2 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Universidad de Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Wilson Canon Montanez, PhD
role: STUDY_DIRECTOR
References:
citation: Garizábalo-Dávila CM, Rodríguez-Acelas AL, Cañon-Montañez W. Soporte social enfocado a personas con diabetes: una necesidad desde enfermería. Rev Cuid. 2019; 10(1): e697. http://dx.doi.org/10.15649/cuidarte.v10i1.697
citation: Garizábalo-Dávila CM, Rodríguez-Acelas AL, Mattiello R, Cañon-Montañez W. Social Support Intervention for Self-Management of Type 2 Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial. Open Access Journal of Clinical Trials. 2021;13:37-43 https://doi.org/10.2147/OAJCT.S314030