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NCT Number: NCT06313138

Effectiveness of 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.

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Key information

Conditions

Multiple Chronic Conditions；Diabetes；Hypertension

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantong University

Nantong, Jiangsu, 226001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Health literacy

    Time frame: 1 week after intervention completion

    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)

Sponsors and collaborators

Lead sponsor

Nantong University

Other

Collaborators

  • Chiang Mai University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.