NCT04298424

Brief Summary

Elderly patients have the deficiency of motivation and confidence in self-management that are mainly influenced by physiological function, social psychology, emotion and low health literacy, resulting in poor self-management and glycemic control. According to the study, elderly patients can learn the skill of self-management more effectively through the peer leaders who have the same culture background, the life experience in disease care and the successful self-management experiences. The Self-Management Program of diabetes for the elderly will be in progress with the peer leadership concept.( the Peer-Led Self-Management Program). The aim of the pilot study was to explore the feasibility and effects of the Peer-Led Self-Management Program (PLSM). This pilot study uses two groups of block randomized controlled trials with pretest and posttest study. The test group will conduct a four-week Peer-Led Self-Management Program and the general outpatient care while the control group will implement the general outpatient care. In this study, the physiological parameters of Diabetes were used to evaluate the difference between the pre-and post-intervention measures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 14, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

February 18, 2020

Last Update Submit

March 4, 2020

Conditions

Keywords

Diabetes Mellitus; Older; Self-Efficacy, Self-Management

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    Hemoglobin A1c, HbA1c

    Change from Baseline HbA1C at 3 months

Secondary Outcomes (2)

  • Self-Management Score

    Change from Baseline Self-Management Score at 3 months

  • Self-Efficacy Score

    Change from Baseline Self-Efficacy Score at 3 months

Study Arms (2)

Peer-led

EXPERIMENTAL

The experimental group will conduct a 4-week peer self-management program and receive the original outpatient routine care.

Other: PLSM

No Peer-led

NO INTERVENTION

The control group will only issue a self-management manual and receive the original outpatient routine care.

Interventions

PLSMOTHER

The program was designed for implementation over 4 consecutive weeks, with groups of 6-8 people each attending one 60-90-minute class per week. Peer leaders lead the groups to promote interaction, sharing, and support, and assist in goal setting to address behavior-related health problems, and thereby the development and implementation of strategies to achieve suitable, sustainable, and feasible self-management behavior.

Peer-led

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age ≥ 65 years,older adult peer leaders with diabetes, elementary school or higher level of education,

You may not qualify if:

  • People with cognitive impairment, severe diabetes complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Martin De Porres Hospital

Chiayi City, Taiwan

RECRUITING

Related Publications (2)

  • Chen WC, Kuo CC, Lin CC, Wu CC. A preliminary study on the effects of the Peer-Led Self-Management (PLSM) program on self-efficacy, self-management, and physiological measures in older adults with diabetes: A block randomized controlled trial. Geriatr Nurs. 2021 Mar-Apr;42(2):386-396. doi: 10.1016/j.gerinurse.2021.01.011. Epub 2021 Feb 20.

  • Chen WC, Lin CC, Kuo CC, Wu CC, Liu TJ, Chen MT. A Theory-Based Self-Management Training Program for Older Adult Peer Leaders with Diabetes: A Feasibility Assessment. J Multidiscip Healthc. 2021 Jan 7;14:33-44. doi: 10.2147/JMDH.S286186. eCollection 2021.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Wen-Chun Chen, Master

    St. Martin De Porres Hospital

    STUDY CHAIR

Central Study Contacts

Wen-Chun Chen, Chief, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

March 6, 2020

Study Start

February 14, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

all collected IPD for study protocol

Shared Documents
STUDY PROTOCOL
Time Frame
starting 6 months after publication
Access Criteria
Email Request

Locations