Clinical trial NCT06313138: Effectiveness of Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity
Official title: Effectiveness of the Individual and Family Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions；Diabetes；Hypertension
Keywords: Aged; multimorbidity; Health literacy; Self-management.
Lead sponsor: Nantong University
Sponsor class: OTHER
Collaborators: name: Chiang Mai University
First posted: 2024-03-15
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;

Primary outcomes:
measure: Self-management
timeFrame: 8 weeks after intervention completion
measure: Treatment burden
timeFrame: 12 weeks after intervention completion
measure: Symptom burden
timeFrame: 12 weeks after intervention completion
Secondary outcomes:
measure: Health literacy
timeFrame: 1 week after intervention completion
Other outcomes:
Locations:
city: Nantong
country: China
facility: Nantong University
state: Jiang Su
Study officials:
affiliation: Nantong University
name: Jun Shan
role: PRINCIPAL_INVESTIGATOR
References: