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Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD

2026年5月3日 更新者:Miaofen Yen、National Cheng Kung University

Exploring Life Experience and Lifestyle Intervention Program Among Patients With Chronic Kidney Disease: A Longitudinal Study

to compare the effectiveness of tailored TTM-based interventions (intervention group) compared to usual care (control group) on biomarkers of kidney function, physical indicators, adoption of health-promoting lifestyle behaviors, kidney disease knowledge, perceived self-efficacy, perceived benefits and barriers to physical activity changes, and quality of life among patients with early-stage CKD over a 30 month period.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Tainan、台湾、70101
        • National Cheng Kung University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

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.

-

Exclusion Criteria:

  1. could not participate in moderate exercise
  2. not able to verbalize understanding of the study
  3. already enrolled in another program.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
他の名前:
  • tailored interventions
介入なし:Control group
Control group only received usual care.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
The Results of eGFR at Each Time Poins From Baseline to 6, 12, 18, 24, and 30 Months
時間枠:The baseline and at 6, 12, 18, 24, and 30 months post intervention

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
The Results of Waist Circumference From Baseline to 6, 12, 18, 24, and 30 Months
時間枠:The baseline and at 6, 12, 18, 24, and 30 months post intervention

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
The Results of Hip Circumference From Baseline to 6, 12, 18, 24, and 30 Months
時間枠:The baseline and at 6, 12, 18, 24, and 30 months post intervention

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
The Results of Health Promotion Lifestyle Behaviors Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
時間枠:The baseline and at 6, 12, 18, 24, and 30 months post intervention

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
The Results of Disease-specific Knowledge of Renal Protection Checklist (RPK) Scales Total Scores From Baseline to 6, 12, 18, 24, and 30 Months
時間枠:The baseline and at 6, 12, 18, 24, and 30 months post intervention

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
The Results of Physical Health QOL Scores From Baseline to 12, and 24 Months
時間枠:The baseline and at 12, 24 months post intervention

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
The Results of Psychological Health QOL Scores From Baseline to 12, and 24 Months
時間枠:The baseline and at 12, 24 months post intervention

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
The Results of Social Relationships QOL Scores From Baseline to 12, and 24 Months.
時間枠:The baseline and at 12, 24 months post intervention

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
The Results of Environment QOL Scores From Baseline to 12, and 24 Months
時間枠:The baseline and at 12, 24 months post intervention

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
The Results of Perceived Self-efficacy of Physical Activity Scores From Baseline to 12, and 24 Months
時間枠:The baseline and at 12, 24 months post intervention

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
The Results of Decisional Balance (Perceived Benefits of Physical Activity) Scores From Baseline to 12, and 24 Months
時間枠:The baseline and at 12, 24 months post intervention

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
The Results of Decisional Balance (Perceived Barrier of Physical Activity) From Baseline to 12, and 24 Months
時間枠:The baseline and at 12, 24 months post intervention

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Miaofen Yen, Doctor、National Cheng Kung University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年8月1日

一次修了 (実際)

2013年7月1日

研究の完了 (実際)

2013年10月1日

試験登録日

最初に提出

2010年8月31日

QC基準を満たした最初の提出物

2010年9月2日

最初の投稿 (推定)

2010年9月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月28日

QC基準を満たした最後の更新が送信されました

2026年5月3日

最終確認日

2023年1月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

De-identified individuals participants data for all primary and secondary outcome measures.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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