NCT01772446

Brief Summary

Introduction: The Spanish Society of Family and Community Medicine, started the Program of Preventive Activities and Health Promotion, which generates periodic recommendations of preventive methods based on scientific evidence. In the last update it has become evident the need of modifications to adapt the program to modern times and focuses on improving accessibility and offering more flexible responses to users of the program. In this sense, the mobile phone technology could be useful, specifically the messaging service to remind patients their appointments and increase attendance rates. Main objective Compare the percentage of patients in the intervention group compared with the control group who achieved a figure of HbA1c \<7% in 2013.Design: single blind Randomized Clinical Trial. Study population: Patients with diabetes with or without hypertension or lipid metabolism disorder, over 18 years, belonging to the Public Health System of Basque Country (primary care) meeting the inclusion / exclusion criteria. Sample size: 238 patients (119 per arm) to detect a difference of 16% in the percentage of patients with HbA1c lower than 7% between groups: Short Messages Standard (SMS) group: Mobile messages reminding the next review of Papps. Control group: Routine clinical practice. Statistical analysis: The relationship between the intervention received and the main variable (compliance with preventive activities at 12 months) were analyzed using a logistic regression model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable diabetes

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

January 10, 2013

Last Update Submit

July 19, 2016

Conditions

Diabetes

Keywords

diabetesmanagementglycated hemoglobinpreventive activities

Outcome Measures

Primary Outcomes (1)

  • Compare the percentage of patients in the intervention group versus the control group who get a HbA1c below 7%

    12 months

Secondary Outcomes (6)

  • Compare the mean change in HbA1c values between SMS group patients and control patients

    6 and 12 months

  • Compare the percentage of patients in the intervention group compared with the control group that meet the following preventive recommendations

    12 months

  • In patients with predictive risk index <1.5, to compare the incidence of diabetic complications in each group

    12 months

  • Evaluate the percentage of patients who are controlled. We consider controlled patient when HbA1C <7%, BP <140/80 and cardiovascular risk <20% measured by the scale of Heart Register of Gerona (REGICOR)

    6 and 12 months

  • To identify factors associated with better compliance of preventive activities in both groups

    12 months

  • +1 more secondary outcomes

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

ROUTINE CLINICAL PRACTICE

SMS MESSAGING

EXPERIMENTAL

SMS MESSAGES TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED HEMOGLOBIN

Behavioral: SMS MESSAGING

Interventions

SMS MESSAGINGBEHAVIORAL

SMS MESSAGING TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED DIABETES

SMS MESSAGING

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetic patients with or without hypertension or lipid metabolism disorder,
  • Aged between 35 and 74 years old with or without hypertension or lipid metabolism disorder,
  • Mobile phone holder,
  • Able to read messages via mobile phone.

You may not qualify if:

  • Pregnant women,
  • Patients whose next date for HbA1c control is less than 2 months
  • Patients with HbA1c \<7%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comarca Araba

Vitoria-Gasteiz, Álava, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemiologist

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 21, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

ES(1)