King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
NCT07917052, Not applicable, Not yet recruiting, Saglik Bilimleri Universitesi
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT07917052 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Saglik Bilimleri Universitesi | ClinicalTrials.gov |
| Conditions | Heart Failure, Cardiac Rehabilitation | ClinicalTrials.gov |
| Interventions | King's Theory of Goal Attainment, Standard Care (in control arm) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Self-Care Behaviors | Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test). | Self-care behaviors will be assessed using a 12-item, 5-point Likert-type scale evaluating treatment adherence, adaptation to daily activities, compliance with recommendations, and help-seeking behaviors. The total score ranges from 12 to 60, with lower scores indicating better self-care behaviors. Scores of 12-36 indicate adequate self-care, whereas scores of 37-60 indicate inadequate self-care. The total scale score will be reported. | ClinicalTrials.gov |
| Primary | Change in Total Physical Activity (MET-minutes/week) | Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test). | Total weekly physical activity will be assessed using self-reported walking, moderate-intensity activity, and vigorous-intensity activity performed during the preceding seven days. Total energy expenditure will be calculated as the sum of walking (3.3 METs), moderate-intensity activity (4.0 METs), and vigorous-intensity activity (8.0 METs), each multiplied by the corresponding duration and weekly frequency. Results will be reported as MET-minutes/week. Higher values indicate greater physical activity. | ClinicalTrials.gov |
| Primary | Change in Physical Activity Classification | Week 1 (Baseline), Week 6, and Week 12. | Participants will be classified into three physical activity categories: Inactive, Minimally Active, and Highly Active, based on self-reported physical activity during the preceding seven days and predefined physical activity scoring criteria. The number of participants in each category will be reported at each assessment time point. | ClinicalTrials.gov |
| Primary | Change in Daily Sitting Time (minutes/day) | Week 1 (Baseline), Week 6, and Week 12. | Self-reported daily sitting time will be assessed as the duration of time spent sitting during the preceding seven days. Results will be expressed in minutes per day. Sitting time will be reported separately from total physical activity energy expenditure. | ClinicalTrials.gov |
| Secondary | Change in Perceived Mattering to Partner Total Score | Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test). | Perceived mattering to one's spouse or partner will be assessed using a 17-item, 5-point Likert-type scale measuring the extent to which participants perceive themselves as cared for, valued, and important to their partners. The total score ranges from 17 to 85, assuming each item is scored from 1 to 5. Higher scores indicate greater perceived mattering to one's partner. The total scale score will be reported. | ClinicalTrials.gov |
| Secondary | Individual Goal Attainment and Self-Management Total Score | Week 6 and Week 12, using weekly monitoring data collected during Weeks 1-12 (intervention group only). | Individual goal attainment and self-management adherence will be assessed using a 20-item composite scoring instrument based on King's Theory of Goal Attainment. The instrument evaluates attainment of predefined individualized goals related to medication adherence, weight and symptom monitoring, physical activity, fluid and salt restriction, educational video engagement, partner involvement, and SMART goal quality. The total score ranges from 0 to 60, with higher scores indicating greater goal attainment and adherence. Weekly WhatsApp reports and telephone follow-up records will provide supporting data for the composite score. | ClinicalTrials.gov |
| Secondary | Change in Body Mass Index (kg/m²) | Baseline (Week 1) and Week 12 | Body Mass Index (BMI) will be calculated by dividing body weight in kilograms by the square of height in meters (kg/m²). BMI will be assessed using routine clinical measurement records. Results will be reported in kg/m². | ClinicalTrials.gov |
| Secondary | Change in Left Ventricular Ejection Fraction (%) | Week 1 (Baseline) and Week 12. | Left ventricular ejection fraction (LVEF) will be obtained from routine echocardiographic assessment records. LVEF represents the percentage of blood ejected from the left ventricle during systole. Results will be expressed as a percentage (%). | ClinicalTrials.gov |
| Secondary | Change in Total Cholesterol (mg/dL) | Week 1 (Baseline) and Week 12. | Serum total cholesterol concentrations will be obtained from routine lipid profile laboratory records. Results will be expressed in milligrams per deciliter (mg/dL). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 17
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 12798836 | BACKGROUND | PubMed |
| 12900694 | BACKGROUND | PubMed |
| 29128777 | BACKGROUND | PubMed |
| 30695817 | BACKGROUND | PubMed |
| 34458905 | BACKGROUND | PubMed |
| 34922348 | BACKGROUND | PubMed |
| 34939499 | BACKGROUND | PubMed |
| 35150240 | BACKGROUND | PubMed |
| 35325562 | BACKGROUND | PubMed |
| 35363499 | BACKGROUND | PubMed |
| 37547123 | BACKGROUND | PubMed |
| 38451843 | BACKGROUND | PubMed |
| 38606657 | BACKGROUND | PubMed |
| 39462344 | BACKGROUND | PubMed |
| 40320893 | BACKGROUND | PubMed |
| 40916514 | BACKGROUND | PubMed |
| 41597311 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)