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

Effectiveness of the Individual and Family Health Literacy Enhancement Program Among Older Persons With Physical Multimorbidity

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.

Study Overview

• Status: Completed
• Conditions: Multiple Chronic Conditions；Diabetes；Hypertension
• Intervention / Treatment: Other: The Individual and Family Enhancement Program

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiang Su
    • Nantong, Jiang Su, China, 226001
      • Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.
Other: control group; Community nurses provide usual care	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-management	Self-management will be measured by Partners in Health (PIH) Scale for older persons with physical multimorbidity which was originally developed by Battersby et al in 2003 and translated into Chinese by Chiu in 2017. The possible total score was between 0 and 96. A higher total score indicates patients with better self-management knowledge and behaviors.	8 weeks after intervention completion
Treatment burden	Treatment burden will be measured by the Treatment Burden Questionnaire (TBQ) initially developed and validated in the France by Tran (2012) and translated into Chinese by Zhang (2021). Each item is scored from 0(not problem) to 10 (big problem) with total scores ranging from 0 (no burden) to 150(high burden). A higher score indicates higher treatment burden.	12 weeks after intervention completion
Symptom burden	Symptom burden will be measured by The Memorial Symptom Assessment Scale Short Form MSAS(MSAS-SF) initially developed by Chang et al (2000) and translated into simplified Chinese language by Fu et al (2018). The total score is the average severity of symptoms within past week, with symptoms not experienced scored as a zero. A higher score equates to greater symptom burden.	12 weeks after intervention completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	Health literacy will be measured by the functional Communication Critical Health Literacy (FCCHL) for older persons with physical multimorbidity which was originally developed by Ishikawa et al (2008) and translated into Chinese by Zhao XY(2021). The total health literacy scale wasformed by adding all fourteen items. Each item is rated on a 4-point Likert scale, ranging from 1 (never) to 4 (often), with a higher score reflecting abundant health literacy. be used to monitor the intermediate outcome of the program implementation and will be measured by the functional Communication Critical Health Literacy (FCCHL)(Ishikawa, Takeuchi, & Yano, 2008) for older persons with physical multimorbidity which was originally developed by Ishikawa et al (2008) and translated into Chinese by Zhao XY(2021)	1 week after intervention completion

Collaborators and Investigators

• Sponsor: Nantong University
• Collaborators: Chiang Mai University
• Investigators: Principal Investigator: Jun Shan, Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Aged; multimorbidity; Health literacy; Self-management.
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: NantongJS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No