Impact of Goal-Directed Care Interventions

NCT06752564 | Not Yet Recruiting

• 1 other identifier: 202301193B0
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract The study explores the effects of a goal-directed care intervention on self-efficacy, symptom distress, and quality of life in patients with multiple chronic conditions. Objective: To evaluate whether patients with multiple chronic conditions exhibit significant improvement in self-efficacy after receiving a goal-directed care intervention compared to their pre-intervention status. To assess whether symptom distress is significantly reduced following the intervention. To determine whether patients experience a significant enhancement in quality of life post-intervention. Background: Global population aging is an ongoing phenomenon with increasing impact worldwide. According to the United Nations Population Report, the average global age in 2019 was 28 years and is projected to rise by 10 years to 38 years by 2050. The proportion of the population aged 65 and above grew from 8% in 1950 to 11% in 2009, and it is expected to reach 22% by 2050. With advances in healthcare quality, the challenges of an aging population are intensifying. Problem-oriented care models, while widely used, are time-intensive and contribute to increased complexity in clinical practice. In contrast, a goal-directed care model focuses on patient-centered outcomes that align with individual priorities rather than addressing each disease separately. This approach reduces conflict and workload for clinical teams while enhancing trust and satisfaction among patients. Goal-directed care is particularly beneficial for patients with multiple chronic conditions, who often face conflicting care options. This study highlights the potential of such an approach to streamline care delivery and improve outcomes in self-efficacy, symptom management, and overall quality of life.

Conditions

Multiple Chronic Diseases

Keywords

quality of life; symptom disorder

Outcome Measures

Primary Outcomes (3)

• Health Self-Efficacy

  The measure of self-efficacy evaluates patients with multiple chronic illnesses, reflecting their confidence in performing specific health-related activities. Participants respond to statements such as, "I am confident that I can eat regularly," or "I can exercise without the company of others." Scores for these health management-related items range from 1 (no confidence at all) to 100 (completely confident).

  After the patient signs the informed consent form, basic demographic data, laboratory reports, and structured questionnaires (self-efficacy, symptom distress, and quality of life) will first be collected. Before intervention program.

• Symptom Distress Scale

  The "Symptom Distress Scale," developed by Lai (1998), is used to assess the severity of symptom distress perceived by the patient. The scale, collaboratively designed by the original author and three experienced cancer clinical care professionals, includes 22 common symptoms faced by cancer patients: nausea, vomiting, appetite issues, insomnia, pain, fatigue, bowel movements, urination, shortness of breath, coughing, bloating, dry mouth, oral/esophageal pain and ulceration, anxiety, concentration problems, appearance, bleeding, shivering/temperature fluctuations, fever, numbness, chest tightness, and heartburn. The scale uses a five-point Likert scoring system: 1. point: "No distress" 2. points: "Mild distress" 3. points: "Moderate distress" 4. points: "Severe distress" 5. points: "Very severe distress" Scores range from 22 to 110, with higher scores indicating greater levels of symptom distress. In this study, the Cronbach's alpha coefficient for the sample was 0.78. The Taiwanese Somat

  After the patient signs the informed consent form, basic demographic data, laboratory reports, and structured questionnaires (self-efficacy, symptom distress, and quality of life) will first be collected. Before intervention program.

• Quality of Life Scale

  The Taiwanese version of the Short Form-36 (SF-36) is a self-reported tool that evaluates health-related quality of life (QoL) across eight dimensions: Physical Functioning (PF) Role Limitations Due to Physical Health (MR) Bodily Pain (BP) General Health (GH) Vitality (V) Social Functioning (SF) Role Limitations Due to Emotional Problems (EP) Mental Health (MH) Each dimension is scored from 0 to 100, where 100 represents excellent health and 0 indicates poor health. The SF-36 includes 36 items corresponding to 8 health domains, divided into two main components: Physical Component Summary (PCS), which includes physical functioning, role limitations due to physical health, bodily pain, and general health. Mental Component Summary (MCS), which includes vitality, social functioning, emotional role, and mental health. Scores range from 0 to 100, with 0 indicating extremely poor health and 100 indicating perfect health.

  After the patient signs the informed consent form, basic demographic data, laboratory reports, and structured questionnaires (self-efficacy, symptom distress, and quality of life) will first be collected. Before intervention program.

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group during hospitalization additionally received 40 minutes of one-on-one education three times a week for three weeks, as the Goal-Oriented Care program for 6 hours in total, followed by telephone sessions of 20 minutes every month for six months post-discharge. Interventions: Behavioral: The Goal-Oriented Care program Behavioral: The routine health education

Behavioral: Goal-Oriented Care Model; Behavioral: standard health education

The control group : standard health education

ACTIVE COMPARATOR

The control group received standard health education. The content of the standard health education included verbal instructions provided by nurses during the general hospital stay, as well as the distribution of educational pamphlets. These instructions covered topics such as the frequency of dialysis and dietary control. The standard health education was generic, without a specific schedule or structured content.

Behavioral: standard health education

Interventions

Goal-Oriented Care Model BEHAVIORAL

The experimental group : Goal-Oriented Care (GOC) The concept of Goal-Oriented Care (GOC) was first introduced by Mold et al. in 1991, addressing the limitations of problem-oriented care, which focuses on eradicating diseases and preventing death. GOC is defined as a process of reaching a consensus on health-related goals between the healthcare team and the patient (Vermunt et al., 2017). It is based on patients' core values and priorities within a clinical context, guiding medical interventions and specific treatment decisions (Secunda et al., 2020). Healthcare professionals using GOC aim to help patients achieve their maximum personal health potential, aligning care with individual goals. The clear direction provided by GOC fosters teamwork and interdisciplinary collaboration (Gray et al., 2020). When establishing long-term goals with patients, it is crucial to revisit and adjust these goals, considering realistic survival timelines, as time plays a vital role in goal-setting.

Experimental

standard health education BEHAVIORAL

The control group received standard health education. The content of the standard health education included verbal instructions provided by nurses during the general hospital stay, as well as the distribution of educational pamphlets. These instructions covered topics such as the frequency of dialysis and dietary control. The standard health education was generic, without a specific schedule or structured content.

Experimental; The control group : standard health education

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with two or more chronic diseases.
• Age ≥ 20 years and \< 80 years.
• Clear consciousness and ability to communicate in Mandarin or Taiwanese dialect.
• Patients who consent to participate in the study after being informed of its purpose.

You may not qualify if:

• Presence of mental health disorders such as schizophrenia
• Bipolar disorder
• Major depressive disorder, etc.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGungMH

Taipei, 10507, Taiwan

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

yuyin Kao

CONTACT

+886929021927; yuyin0020@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: January 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)