Self-EfficacyNCT04298424
the Peer-Led Self-Management Program
A study testing PLSM in people with Self-Efficacy and Self-Management, run by St. Martin De Porress Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Self-Efficacy, Self-Management, Older Adults
- What is being tested?
- PLSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Feb 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥ 65 years,older adult peer leaders with diabetes, elementary school or higher level of education,
Who cannot join
- People with cognitive impairment, severe diabetes complications
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
St. Martin De Porres Hospital
Chiayi City
Wen-Chun Chen, Master
About this study
Official title: Effects of the Peer-Led Self-Management Program (PLSM) on Self-Efficacy, Self-Management and Physiological Measures Among Elderly Patients With Diabetes: Pilot Randomized Controlled Trial
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.
Read the detailed description
Most current self-management programs are developed for implementation by healthcare professionals. These professionals cannot fully perceive disease management needs and obstacles of older adults due to a lack of similar illness experience. To develop a self-management training program for older adult peer leaders with diabetes and to assess its feasibility.
This study was conducted in three stages. In stage 1, the peer leader training program was developed using experiential learning theory as the framework and self-regulation theory as the strategy for activity design. The 4-week training program was implemented for 4 hours/week. In stage 2, the feasibility of the training program was assessed. A peer leader training assessment tool was developed and used to evaluate peer leaders' leadership skills for self-management programs. Peer leaders' attendance rate and their viewpoints toward the training program through qualitative interview, willingness to lead self-management programs for older adults with diabetes in the community in the future were also assessed. In stage 3, This pilot study will take elderly diabetic patients in a community health station in Taiwan. The program will be conducted by peer leaders who have completed training to lead elderly diabetic patients and promote interaction, sharing, and support among peers. Improve self-confidence by guiding elderly diabetic patients to reflect on past self-management challenges and share successful self-management experiences. At the same time, learn how to find self-management problems, set goals and develop action plans, and other strategies to help elderly patients with diabetes set goals for their own health problems, develop and implement self-suitable, feasible and sustainable self-management behaviors to strengthen Self-management skills for elderly diabetic patients. The 4-week program was implemented for 2 hours/week.
- Conditions
- Self-Efficacy, Self-Management, Older Adults, Diabetes
- Being tested
- PLSM
- Keywords
- Diabetes Mellitus; Older; Self-Efficacy, Self-Management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-led | Experimental | The experimental group will conduct a 4-week peer self-management program and receive the original outpatient routine care. Receives: Other: PLSM |
| No Peer-led | No intervention | The control group will only issue a self-management manual and receive the original outpatient routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Hemoglobin A1c, HbA1c
Measured: Change from Baseline HbA1C at 3 months
Secondary outcomes (2)
Self-Management Score
Diabetes Self-Management Instrument Short Form, DSMI-20
Measured: Change from Baseline Self-Management Score at 3 months
Self-Efficacy Score
The Diabetes Management Self-Efficacy Scale, DMSES
Measured: Change from Baseline Self-Efficacy Score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start14 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self-EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Martin De Porress Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Chun Chen, Master, Study chair, St. Martin De Porres Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298424
- Sponsor's protocol ID
- 17B-023
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD for study protocol
Publications
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.
PubMed 33621782Chen 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.
PubMed 33442261
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Peer-Led Self-Management Program (PLSM) on Self-Efficacy, Self-Management and Physiological Measures Among Elderly Patients With Diabetes: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04298424
- Acronym / sponsor ID
- 17B-023
- Conditions
- Self-Efficacy, Self-Management, Older Adults, Diabetes
- Keywords
- Diabetes Mellitus; Older; Self-Efficacy, Self-Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Martin De Porress HospitalUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Most current self-management programs are developed for implementation by healthcare professionals. These professionals cannot fully perceive disease management needs and obstacles of older adults due to a lack of similar illness experience. To develop a self-management training program for older adult peer leaders with diabetes and to assess its feasibility.
This study was conducted in three stages. In stage 1, the peer leader training program was developed using experiential learning theory as the framework and self-regulation theory as the strategy for activity design. The 4-week training program was implemented for 4 hours/week. In stage 2, the feasibility of the training program was assessed. A peer leader training assessment tool was developed and used to evaluate peer leaders' leadership skills for self-management programs. Peer leaders' attendance rate and their viewpoints toward the training program through qualitative interview, willingness to lead self-management programs for older adults with diabetes in the community in the future were also assessed. In stage 3, This pilot study will take elderly diabetic patients in a community health station in Taiwan. The program will be conducted by peer leaders who have completed training to lead elderly diabetic patients and promote interaction, sharing, and support among peers. Improve self-confidence by guiding elderly diabetic patients to reflect on past self-management challenges and share successful self-management experiences. At the same time, learn how to find self-management problems, set goals and develop action plans, and other strategies to help elderly patients with diabetes set goals for their own health problems, develop and implement self-suitable, feasible and sustainable self-management behaviors to strengthen Self-management skills for elderly diabetic patients. The 4-week program was implemented for 2 hours/week.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-led | Experimental | Other: PLSMThe experimental group will conduct a 4-week peer self-management program and receive the original outpatient routine care. |
| No Peer-led | No intervention | –The control group will only issue a self-management manual and receive the original outpatient routine care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age ≥ 65 years,older adult peer leaders with diabetes, elementary school or higher level of education,
Key exclusion criteria (1 listed)
- People with cognitive impairment, severe diabetes complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLSMThe 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. | Other | Peer-led |
Primary outcome
HbA1C
Time frame: Change from Baseline HbA1C at 3 months
Hemoglobin A1c, HbA1c
2 secondary outcomes
Self-Management Score
Time frame: Change from Baseline Self-Management Score at 3 months
Self-Efficacy Score
Time frame: Change from Baseline Self-Efficacy Score at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 33621782Chen 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.
- Derived from this study: PubMed 33442261Chen 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.
- Individual participant dataSharing planned: Yes. all collected IPD for study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Chun Chen, Master study chair
St. Martin De Porres Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLSM in people with Self-Efficacy and Self-Management, run by St. Martin De Porress Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Chun Chen, Chief, Master (+886-5-2756000 ext. 3310, shermie@stm.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: Change from Baseline HbA1C at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298424, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.