Clincosm LogoSign in Get a demo

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

Sponsor
Universidad de Antioquia (Other)
Overall Status
Completed
CT.gov ID
NCT04491253
Collaborator
(none)
94
Enrollment
1
Location
2
Arms
5.2
Actual Duration (Months)
18.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social support for diabetes self-management
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of a Social Support Intervention in Adults for Self-management of Type 2 Diabetes Mellitus
Actual Study Start Date :
Sep 13, 2021
Actual Primary Completion Date :
Feb 18, 2022
Actual Study Completion Date :
Feb 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Behavioral: Social support for diabetes self-management
Four individualized intervention sessions, every two weeks with a duration of 40 minutes.
No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Self-management: diabetes [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 Outcome Measures

  1. Social support [2 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad de Antioquia Medellín Colombia

Sponsors and Collaborators

  • Universidad de Antioquia

Investigators

  • Study Director: Wilson Canon Montanez, PhD, Universidad de Antioquia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT04491253
Other Study ID Numbers:
  • 2020-04
First Posted:
Jul 29, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidad de Antioquia
Nursing Outcomes Classification Terminology
Self-management
Social support
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 24, 2022