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

NCT ID: NCT04491253

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2022-02-18

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

The intervention is defined as informational support (transmission of information for health care, knowledge of DM2, nutrition, physical activity), instrumental (physical care) and emotional (management of anxiety, empowerment and decision-making).

Group Type: EXPERIMENTAL

Social support for diabetes self-management

Intervention Type: BEHAVIORAL

Four individualized intervention sessions, every two weeks with a duration of 40 minutes.

Control

Control group will receive usual care treatment at the diabetes mellitus nursing consultation in primary care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Social support for diabetes self-management

Four individualized intervention sessions, every two weeks with a duration of 40 minutes.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Canon Montanez, PhD

Role: STUDY_DIRECTOR

Universidad de Antioquia

Locations

Universidad de Antioquia

Medellín, , Colombia

Countries

Colombia

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

2020-04

Identifier Type: -

Identifier Source: org_study_id