Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD
Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
A thirty-month clinical trial (ClinicalTrials.gov registration NCT01194518) was conducted from October 2010 through October 2013. The CONSORT checklist (Schulz et al., 2010) guided the study. Data were collected at baseline and at 6, 12, 18, 24, and 30 months post-intervention.
Participants and Setting After obtaining approval to conduct the study from the Institutional Review Board, the nephrology case managers from the outpatient clinics of two medical centers in southern Taiwan were contacted and asked to refer patients to the study. Participants were included if they were at least 20 years old, diagnosed with stages 1 to 3 CKD, spoke Mandarin, and could be followed up every 6 months when they returned for an outpatient visit. Patients who were unable to participate in moderate exercise, unable to verbalize that they understood the study, or were already enrolled in another program were excluded. Upon obtaining written informed consent subjects were randomly assigned to the control or intervention group at a ratio of 1 to 1 using paper ballots.
The Bureau of National Health Insurance (BNHI) in Taiwan launched the CKD care program for pre-ESRD care which suggested that CKD management and education depended on the stage of CKD (Chen et al., 2011). In addition, Taiwan established a medical system protocol to standardize and regulate pre-ESRD care with all medical expenditures covered by the National Health Insurance (NHI). Therefore, patients receive regular follow-ups as nephrology outpatients with the nephrology case managers providing usual care.
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Tainan, Taiwan, 70101
- National Cheng Kung University
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Inclusion Criteria:
1.at least 20 years old 2. diagnosed as stage 1-3 CKD (eGFR greater than ≧ 44 ml/min per 1.73 m2), 3. spoke Mandarin, 4.could be followed up every 6 months when they returned for a clinic outpatient visit.
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Exclusion Criteria:
- could not participate in moderate exercise
- not able to verbalize understanding of the study
- already enrolled in another program.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Intervention group
Intervention groups completed the stage-of-change and readiness-to-change assessments.
Intervention groups were provided tailored interventions based on the premise that patient response to physical activity in stages for lifestyle counseling from baseline, 6, 12,18 24, and 30 months.
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The tailored intervention made use of the 10 processes of change, important guides for developing intervention programs, which have received the most empirical support to date.
The 10 processes include consciousness raising, dramatic relief, self-reevaluation, environmental reevaluation, self-liberation, social liberation, counterconditioning, stimulus control, reinforcement management, and helping relations.
The different tailored interventions were based on the processes of change matched to the patient's stage of change, providing strategies that may be especially helpful to patients.
According to the Lenio analysis of the TTM model of behavior change, the first five processes are used in the early stages, and the last five are used in the later stages.
Altri nomi:
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Nessun intervento: Control group
Control group only received usual care.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
Lasso di tempo: The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) formula (eGFR (ml/min/1.73 m2) = 186 × (SCr)-1.154 × (Age)-0.203 × (0.742 if female) (National Kidney Foundation, 2002). The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data. |
The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
Lasso di tempo: The baseline and at 6, 12, 18, 24, and 30 months post intervention
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Waist circumference in centimeters was measured at the level midway between the lowest rib margin and the iliac crest at baseline, 6, 12, 18, 24, and 30 months for each intervention. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data. |
The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
Lasso di tempo: The baseline and at 6, 12, 18, 24, and 30 months post intervention
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Hip circumference was measured at the widest area over the trochanters at 6, 12, 18, 24, and 30 months of every intervention. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data. |
The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
Lasso di tempo: The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The HPLP-II is validated, Self-report questionnaires Health promotion lifestyle was measured by the 52-item Health-Promoting Lifestyle-II (HPLP-II) Chinese questionnaire. The total scores of the HPLP-II are determined by calculating a mean item response. The HPLP-II uses mean sums of scale items to remain the 1 to 4 metric of item. Higher scores indicated better health-promoting lifestyle behaviors. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data. |
The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
Lasso di tempo: The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The renal protection checklist (RPK) is validated, Self-report questionnaires a disease-specific knowledge of renal protection checklist were developed by Yen, Huang, and Teng in 2008. The checklist consists of 20 items including three domains: renal function protection (11 items), knowledge of Chinese herbal medicine related to renal function (5 items), and diet with CKD (4 items). Item responses were "true" or "false." Each item is scored with 5 points for each correct answer. The total scores for the checklist range from 0-100. Higher scores indicate higher knowledge of renal function protection. The results were presented at each time point from baseline to 6, 12,18,24, and 30 months after follow-up data. |
The baseline and at 6, 12, 18, 24, and 30 months post intervention
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The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results presented the physical health QOL scores at each time point from baseline to 12, and 24 months. |
The baseline and at 12, 24 months post intervention
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The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the psychological health QOL scores from baseline to 12, and 24 Months. |
The baseline and at 12, 24 months post intervention
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The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the Social Relationships QOL scores at each time point from baseline to 12, and 24 months. |
The baseline and at 12, 24 months post intervention
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The Results of Environment QOL Scores From Baseline to 12, and 24 Months
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The WHOQOL-BREF Taiwanese version is validated, as Self-report questionnaires. The WHOQOL-BREF Taiwanese version was evaluated using 26 items. The WHOQOL-BREF Taiwanese version incorporates four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environment (9 items). Using a 5-point Likert scale from 1 "not satisfied at all" to 5 "extremely satisfied", higher scores indicate a better QOL. Each domain's score ranged from 4 to 20, which was calculated by multiplying the average of the scores of all items in the domain by four. The results present the Environment QOL scores at each time point from baseline to 12, 24 months. |
The baseline and at 12, 24 months post intervention
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The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The Perceived self-efficacy of physical activity is validated, and the Self-report questionnaire. The perceived self-efficacy scale was used to measure perceived self-efficacy for physical activity. Fifteen items are answered on a six-point Likert scale ranging from 1 (completely uncertain) to 6 (completely certain). The total score ranges from 15-90, with a higher score representing greater perceived self-efficacy for physical activity. The results present the Perceived self-efficacy of physical activity scores at each time point from baseline to 12, and 24 months. |
The baseline and at 12, 24 months post intervention
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The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the benefits of changing physical activity behaviors (14 items) and the total score range from 14-84. The higher the scores represent the perceived benefits of physical activity is higher. The results present the Decisional balance (perceived benefits of physical activity) scores at each time point from baseline to 12, and 24 months. |
The baseline and at 12, 24 months post intervention
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The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
Lasso di tempo: The baseline and at 12, 24 months post intervention
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The Decisional Balance Scale measures the perceived benefits and barriers of physical activity on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). The scale of the barrier of changing physical activity behaviors (15 items) and the total score range from 15-90. The higher the scores represent the perceived barrier to physical activity is higher. The results present the Decisional Balance (Perceived Barrier of Physical Activity) scores at each time point from baseline to 12, and 24 months. |
The baseline and at 12, 24 months post intervention
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Miaofen Yen, Doctor, National Cheng Kung University
Pubblicazioni e link utili
Pubblicazioni generali
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- Teng HL, Yen M, Fetzer S, Sung JM, Hung SY. Effects of targeted interventions on lifestyle modifications of chronic kidney disease patients: randomized controlled trial. West J Nurs Res. 2013 Oct;35(9):1107-27. doi: 10.1177/0193945913486202. Epub 2013 Apr 25.
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Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
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Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattia cronica
- Attributi della malattia
- Insufficienza renale
- Condizioni patologiche, segni e sintomi
- Comportamento
- Insufficienza renale cronica
- Comportamento sanitario
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- NSC992314B006048MY3
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .