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

NCT06313138 | Completed DMC

• 1 other identifier: NantongJS
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Multiple Chronic Conditions；Diabetes；Hypertension

Keywords

Aged; multimorbidity; Health literacy; Self-management.

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Health literacy

  1 week after intervention completion

Study Arms (2)

Interventional group

EXPERIMENTAL

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

control group

OTHER

Community nurses provide usual care

Other: The Individual and Family Enhancement Program

Interventions

The Individual and Family Enhancement Program 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.

Interventional group; control group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nantong University: lead
• Chiang Mai University: collaborator

Study Sites (1)

Nantong University

Nantong, Jiangsu, 226001, China

Location

Study Officials

• Jun Shan

  Nantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Candidate

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: March 15, 2024
• Study Start: July 15, 2023
• Primary Completion: December 25, 2023
• Study Completion: January 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)