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Clinical Trials/NCT06313138
NCT06313138
Completed
Not Applicable

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

Nantong University1 site in 1 country140 target enrollmentJuly 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Chronic Conditions;Diabetes;Hypertension
Sponsor
Nantong University
Enrollment
140
Locations
1
Primary Endpoint
Self-management
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2023
End Date
January 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nantong University
Responsible Party
Principal Investigator
Principal Investigator

Jun Shan

Phd Candidate

Nantong University

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;

Outcomes

Primary Outcomes

Self-management

Time Frame: 8 weeks after intervention completion

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.

Treatment burden

Time Frame: 12 weeks after intervention completion

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.

Symptom burden

Time Frame: 12 weeks after intervention completion

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.

Secondary Outcomes

  • Health literacy(1 week after intervention completion)

Study Sites (1)

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