The Effect of Telephone Consulting on HbA1 and Self-Management
1 other identifier
interventional
63
1 country
1
Brief Summary
The aim of this study was to investigate the effect of telephone counseling (12 weeks) based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jan 2019
Shorter than P25 for not_applicable type-2-diabetes
1 active site
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
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedFirst Submitted
Initial submission to the registry
January 18, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2021
CompletedJanuary 26, 2021
January 1, 2021
9 months
January 18, 2021
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic Control
Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.
3 months
Secondary Outcomes (3)
Type 2 Diabetes Self-Efficacy Scale
3 months
Diabetes Self-Management Questionnaire (DSMQ)
3 months
Perceived Diabetes Self-Management Scale (PDSMS)
3 months
Study Arms (2)
Experimental group
EXPERIMENTALThen, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks.
Control group
NO INTERVENTIONAll data forms were then completed, and the HbA1c value was taken from the medical data. No additional procedure was performed to the control group. The research data were collected again at the end of 12 weeks.
Interventions
Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis with type 2 DM at least six months previously
- Using a mobile phone
- HbA1c greater than 7%
- Living in the city
- Physical and mental health levels adequate for participation in the research
You may not qualify if:
- Having severe hearing or perceptual deficits that impaired communication
- Patients who did not agree to participate in the study
- Receiving inpatient treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kadriye Sayin Kasar
Aksaray, İlçe Seçiniz, 68100, Turkey (Türkiye)
Related Publications (1)
Sayin Kasar K, Duru Asiret G, Kutmec Yilmaz C, Canlar S. The effect of model-based telephone counseling on HbA1c and self-management for individuals with type 2 diabetes: A randomized controlled trial. Prim Care Diabetes. 2022 Feb;16(1):41-48. doi: 10.1016/j.pcd.2021.09.005. Epub 2021 Sep 11.
PMID: 34518109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, RN
Study Record Dates
First Submitted
January 18, 2021
First Posted
January 26, 2021
Study Start
January 1, 2019
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share