NCT02594748

Brief Summary

The aims of the study are as follows:

  • To improve self-management intention and behavior of patients with type 2 diabetes (T2 DM).
  • To promote patients to make plans for their self-management and gradually integrate the self-management plan into their daily life.
  • To improve resilience, well-being, fatigue and quality of life of patients with T2 DM In order to achieve the aims, we have set the following objectives:
  • To develop and apply self-management education program based on the extended theory of planned behavior.
  • To evaluate the efficacy of the educational program:
  • Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
280

participants targeted

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

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
suspended

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

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

October 27, 2015

Last Update Submit

October 24, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.

    Measure the impact and important of 19 life domains.

    baseline and at three months.

Secondary Outcomes (8)

  • Change from baseline in Fatigue-14 scale at 3-month follow up.

    Baseline,3-month follow up.

  • Change from baseline in Well-Being Index (WHO-5)

    Baseline,3-month follow up.

  • Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up.

    Baseline,3-month follow up.

  • Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.

    Baseline,3-month follow up.

  • Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.

    Baseline,3-month follow up.

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Intervention is administered to patients in this Arm. The intervention is self-management education based on the theory of planned behavior(TPB). The intervention of experimental group is individual guide and face to face education based on TPB.

Behavioral: Self-management education

Comparison group

ACTIVE COMPARATOR

The comparison group will receive routine care

Behavioral: Routine care

Interventions

Self-management educationBEHAVIORAL

The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .

Experimental group
Routine careBEHAVIORAL

They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital

Comparison group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 years
  • duration of type 2 diabetes ≥3 months
  • without any severe complication and impaired cognition.

You may not qualify if:

  • severe physical handicap or mental illness
  • presence of other serious disease such as cancer and stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People Hospital, Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

Related Publications (1)

  • Zhao FF, Suhonen R, Katajisto J, Stolt M, Leino-Kilpi H. Association between diabetes-related self-care activities and positive health: a cross-sectional study. BMJ Open. 2019 Jul 9;9(7):e023878. doi: 10.1136/bmjopen-2018-023878.

    PMID: 31289048DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Helena leino-kilpi, PhD

    Department of Nursing Science, Universtiy of Turku

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

October 27, 2015

First Posted

November 3, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2019

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)