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Clinical Trials/NCT04491253
NCT04491253
Completed
N/A

Efficacy of a Social Support Intervention in Adults for Self-management of Type 2 Diabetes Mellitus

Universidad de Antioquia1 site in 1 country94 target enrollmentSeptember 13, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Universidad de Antioquia
Enrollment
94
Locations
1
Primary Endpoint
Self-management: diabetes
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2021
End Date
February 18, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Self-management: diabetes

Time Frame: 2 months

NOC outcome. Personal actions to manage diabetes, its treatment, and to prevent complications. Indicators of participation in self-management behaviors, specifically healthy eating, physical exercise, glucose monitoring and symptom management. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.

Secondary Outcomes

  • Social support(2 months)

Study Sites (1)

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