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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Social support for diabetes self-management


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Four individualized intervention sessions, every two weeks with a duration of 40 minutes.<br>|
| No Intervention: Control<br>Control group will receive usual care treatment at the diabetes mellitus nursing consultation in primary care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing Outcomes Classification Terminology, Self-management, Social support