NCT04491253

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

July 24, 2020

Last Update Submit

February 23, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

Nursing Outcomes Classification TerminologySelf-managementSocial support

Outcome Measures

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.

    2 months

Secondary Outcomes (1)

  • Social support

    2 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Social support for diabetes self-managementBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Antioquia

Medellín, Colombia

Location

Related Publications (2)

  • 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

    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

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Wilson Canon Montanez, PhD

    Universidad de Antioquia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 29, 2020

Study Start

September 13, 2021

Primary Completion

February 18, 2022

Study Completion

February 18, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)