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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Social support for diabetes self-management
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Nursing Outcomes Classification Terminology, Self-management, Social support

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Universidad de Antioquia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 24, 2020
Last Updated
February 23, 2022
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT04491253
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Nursing Outcomes Classification Terminology, Self-management, Social support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will receive usual care treatment at the diabetes mellitus nursing consultation in primary care.
Intervention Type
Behavioral
Intervention Name(s)
Social support for diabetes self-management
Intervention Description
Four individualized intervention sessions, every two weeks with a duration of 40 minutes.
Primary Outcome Measure Information:
Title
Self-management: diabetes
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Social support
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson Canon Montanez, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
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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
Results Reference
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Social Support Intervention for Self-management of Type 2 Diabetes Mellitus

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