Social Support Intervention for Self-management of Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491253
• Other study ID #: 2020-04
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: February 2022
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Social support for diabetes self-management
Four individualized intervention sessions, every two weeks with a duration of 40 minutes.

Locations

Country	Name	City	State
Colombia	Universidad de Antioquia	Medellín

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (2)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-management: diabetes	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.	2 months
Secondary	Social support	NOC outcome. Reliable assistance from others. Indicators of emotions, stress, communication, decision-making, empowerment, trust, support groups and networks. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.	2 months