CClinicalTrials.gg
CompletedNCT04491253Updated Feb 24, 2022

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

An interventional study of Social support for diabetes self-management in Diabetes Mellitus, Type 2, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Nursing Outcomes Classification Terminology
  • Self-management
  • Social support
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 94 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • 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

  • No intervention
    Control

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

Interventions

  • BehavioralSocial support for diabetes self-management

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

Secondary outcomes

  1. 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.

    Time frame: 2 months

07

Study locations

1 site
  • Universidad de Antioquia
    Medellín, Colombia
08

References and documents

Publications

  • 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

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04491253
Lead sponsor
Universidad de Antioquia
Responsible party
Sponsor
First posted
Jul 29, 2020
Start date
Sep 13, 2021
Primary completion
Feb 18, 2022
Completion
Feb 18, 2022
Last update
Feb 24, 2022

Study contacts

Wilson Canon Montanez, PhD
study director · Universidad de Antioquia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion