Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity

NCT ID: NCT06313138

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2024-01-30

Brief Summary

The study aims to examine the effectiveness of individual and family health literacy enhancement program among older persons with physical multimorbidity.

Specific objectives are:

1. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between before and after receiving the individual and family health literacy enhancement program.

2. To compare self-management, treatment burden, and symptom burden of older persons with physical multimorbidity between those receiving the individual and family health literacy enhancement program and those receiving usual care.

Participants in the control group will receive usual care by physician and nurses during the experimental period. The usual care consists of physical examination, regular treatment protocol, patient education and telephone follow-up by community nurses.

Participants in the interventional group will receive the program which is a group-based intervention developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.The program will be divided into 8 sessions. Each session will be lasted for 2 hours with 1 intermittent break (10 minutes), and it will be held twice a week, and the last session will be held 1 week after the 7th session. Therefore, it will last for 5 weeks in total.

Conditions

Multiple Chronic Conditions；Diabetes；Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Interventional group

The Individual and Family Enhancement Program Session 1(1st week): Assessment and exchange information and building trusting relationship between researcher and participants; Session 2-3(1st-2nd week): Information sharing based on PITS model (Pathophysiology, Symptoms, or signs) and evaluation participants' understanding based on UPP scale.

Session 4-5(2nd-3rd week): Information sharing based on PITS model (treatment) and health maintenance skills.

Session 6 (3rd week): Information sharing based on PITS model (specifics) and family role in self-management.

Session7(4th week): Evaluation and summary. Session 8(5th week): Assess health literacy and information provision

Group Type: EXPERIMENTAL

The Individual and Family Enhancement Program

Intervention Type: OTHER

The program is a group-based intervention which will be developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.

control group

Community nurses provide usual care

Group Type: OTHER

The Individual and Family Enhancement Program

Intervention Type: OTHER

The program is a group-based intervention which will be developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.

Interventions

The Individual and Family Enhancement Program

The program is a group-based intervention which will be developed by the researcher based on the Individual and Family Self-Management Theory (IFSMT) (self-management skills) and the principle of Medagogy (PITS model: Pathophysiology, Indications, Treatments, Specifies) to improve patients' and their families' understanding of disease-related information and self-management skills consisting of goal setting and action plan, self-monitoring, solving problems and decision-making, and emotional control.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 60-80 years old;
• Having been diagnosed with hypertension and type 2 diabetes for at least 6 months;
• Being able to read and write Chinese language;
• Cognitive intact as measured by the Mini-Mental State Examination (MMSE) with the score ≥ 24;
• Physically independence as measured by the Barthel ADL Index and the score above 12 out of 20 ;
• Willing to participate in the study;
• Having at least a family member who is willing to participate in the study.

Exclusion Criteria

• Having other diseases or severe complications from their health problems that making them unable to fully participate through all process of the program including ischemic heart disease, myocardial infarction, heart failure, stroke, acute renal failure, diabetic ketoacidosis, and diabetic coma;

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: collaborator

Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Jun Shan

Phd Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Shan

Role: PRINCIPAL_INVESTIGATOR

Nantong University

Locations

Nantong University

Nantong, Jiangsu, China

Countries

China

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NantongJS

Identifier Type: -

Identifier Source: org_study_id