Mobile Health Application for Family Caregivers in Home Palliative Care (CARE-Mobile)
Effectiveness of a Mobile Health Application for Family Caregivers of Patients Receiving Home Palliative Care: A Randomized Controlled Trial
Family caregivers play a central role in providing daily care for patients receiving home palliative care. However, caregiving responsibilities may lead to increased burden, stress, and difficulties in symptom management and care coordination. Mobile health (mHealth) interventions may provide accessible education, symptom monitoring, and decision-support resources to improve caregiver outcomes and patient care.
The aim of this randomized controlled trial is to evaluate the effectiveness of a mobile health application developed for family caregivers of patients receiving home palliative care. The primary outcome is caregiver competence. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.
A total of 120 family caregivers will be randomly assigned to either the intervention group, which will use the mobile health application for 6 weeks in addition to usual care, or the control group, which will receive usual care alone. Outcomes will be assessed at baseline, post-intervention (Week 6), and follow-up (Week 18).
調査の概要
詳細な説明
Home palliative care services increasingly rely on family caregivers to provide symptom management, daily care, medication support, and coordination of healthcare services. Although family caregivers play a critical role in maintaining patient well-being, they frequently experience caregiving burden, psychological distress, and challenges in managing complex care needs. Strengthening caregiver competence and self-management skills may improve both caregiver and patient outcomes.
Mobile health technologies offer an opportunity to deliver structured educational and supportive interventions independent of time and location. Despite growing interest in digital health interventions, evidence regarding mobile applications specifically designed for family caregivers in home palliative care remains limited.
This study is a single-center, parallel-group, randomized controlled trial conducted at the Home Care Unit of Simav Doc. Dr. Ismail Karakuyu State Hospital, Kutahya, Türkiye. A total of 120 family caregivers of patients receiving home palliative care will be recruited and randomly allocated in a 1:1 ratio to either an intervention group or a control group.
Participants in the intervention group will receive access to a mobile health application developed for family caregivers. The application includes educational modules on palliative care and symptom management, daily care skills, medication management, nutrition and hygiene, prevention of pressure injuries, caregiver self-care, stress management, problem-solving, and decision-making regarding healthcare utilization. Participants will receive a brief orientation session and will use the application for 6 weeks. Application usage data will be recorded to assess intervention adherence.
Participants in the control group will continue to receive routine home palliative care services without access to the mobile application.
The primary outcome is caregiver competence, measured using the Care Competency Scale for Family Caregivers in Home Palliative Care. Secondary outcomes include caregiver burden, caregiver self-efficacy, patient symptom burden, emergency department visits, and hospitalizations. Assessments will be conducted at baseline (Week 0), immediately after the intervention period (Week 6), and at follow-up (Week 18).
The study is expected to provide evidence regarding the effectiveness of a mobile health intervention for improving caregiver competence and supporting patient care in home palliative care settings.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Serkan Budak, PhD / RN
- 電話番号：+905385430616
- メール：serkan.budak@ksbu.edu.tr
研究場所
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Kütahya
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Simav、Kütahya、トルコ（Türkiye）、43500
- 募集
- Simav Doc. Dr. Ismail Karakuyu State Hospital
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コンタクト：
- Serkan Budak
- 電話番号：905385430616
- メール：serkan.budak@ksbu.edu.tr
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Family caregiver of a patient receiving home palliative care services.
- Aged 18 years or older.
- Providing unpaid care to the patient for at least 3 months.
- Able to read and understand Turkish.
- Owns or has regular access to a smartphone compatible with the mobile application.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Professional or paid caregivers.
- Participation in another structured caregiver support program during the study period.
- Cognitive, visual, or hearing impairments that would prevent effective use of the mobile application.
- Inability to complete study assessments.
- Withdrawal of consent at any stage of the study.
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Mobile Health Application Plus Usual Care
Participants will receive access to a mobile health application designed for family caregivers of patients receiving home palliative care in addition to routine home palliative care services.
The intervention will be delivered for 6 weeks and includes educational content, symptom management support, caregiver self-care resources, medication management guidance, and healthcare utilization decision support.
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Participants in the intervention group will receive access to a mobile health application developed for family caregivers of patients receiving home palliative care.
The application includes educational modules on palliative care and symptom management, daily care skills, medication management, nutrition and hygiene, pressure injury prevention, caregiver self-care, stress management, problem-solving, and healthcare utilization decision support.
Participants will use the application for 6 weeks in addition to routine home palliative care services.
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介入なし：Usual Care Alone
Participants will receive routine home palliative care services provided by the home care unit.
No mobile health application or additional structured intervention will be provided during the study period.
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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 |
|---|---|---|
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Care Competency Scale for Family Caregivers in Home Palliative Care
時間枠：Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Caregiver competence will be assessed using the Care Competency Scale for Family Caregivers in Home Palliative Care.
The scale consists of 29 items scored on a 1-5 Likert scale and evaluates caregiving knowledge, skills, preparedness, relational competence, emotional competence, and support-seeking competence.
Total scores range from 29 to 145, with higher scores indicating greater caregiver competence.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Zarit Burden Interview
時間枠：Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Caregiver burden will be assessed using the Zarit Burden Interview.
The scale consists of 22 items scored on a 5-point Likert scale.
Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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General Self-Efficacy Scale
時間枠：Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Caregiver self-efficacy will be assessed using the General Self-Efficacy Scale.
The scale consists of 10 items scored on a 4-point Likert scale.
Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Integrated Palliative Care Outcome Scale (IPOS) - Proxy Version
時間枠：Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Patient symptom burden will be assessed using the proxy version of the Integrated Palliative Care Outcome Scale (IPOS).
The scale evaluates physical symptoms, emotional concerns, communication, and practical needs.
Total scores range from 0 to 68, with higher scores indicating greater symptom burden and unmet needs.
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Baseline, post-intervention at 6 weeks, and follow-up at 18 weeks
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Emergency Department Visits
時間枠：During the 18-week study period
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Emergency department visits will be assessed as the number of emergency department admissions occurring during the study period.
Higher values indicate greater healthcare utilization.
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During the 18-week study period
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Hospitalizations
時間枠：During the 18-week study period
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Hospitalizations will be assessed as the number of inpatient hospital admissions occurring during the study period.
Higher values indicate greater healthcare utilization.
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During the 18-week study period
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mobile Application Login Frequency
時間枠：During the 6-week intervention period
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The total number of application logins during the intervention period will be recorded using system-generated log data.
Higher values indicate more frequent use of the mobile application.
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During the 6-week intervention period
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Mobile Application Use Duration
時間枠：During the 6-week intervention period
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The total duration of application use, measured in minutes, will be recorded using system-generated log data during the intervention period.
Higher values indicate greater use of the mobile application.
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During the 6-week intervention period
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Educational Module Completion Rate
時間枠：During the 6-week intervention period
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The percentage of educational modules completed during the intervention period will be recorded using system-generated log data.
Higher percentages indicate greater adherence to the educational intervention.
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During the 6-week intervention period
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Monitoring Activity Completion Rate
時間枠：During the 6-week intervention period
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The percentage of scheduled monitoring activities completed during the intervention period will be recorded using the Mobile Application Usage and Monitoring Form and system-generated log data.
Higher percentages indicate greater adherence to monitoring activities.
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During the 6-week intervention period
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Kelley MM, Powell T, Camara D, Shah N, Norton JM, Deitelzweig C, Vaidy N, Hsiao CJ, Wang J, Bierman AS. Mobile Health Apps, Family Caregivers, and Care Planning: Scoping Review. J Med Internet Res. 2024 May 23;26:e46108. doi: 10.2196/46108.
- Yang X, Li X, Jiang S, Yu X. Effects of Telemedicine on Informal Caregivers of Patients in Palliative Care: Systematic Review and Meta-Analysis. JMIR Mhealth Uhealth. 2024 Apr 8;12:e54244. doi: 10.2196/54244.
- Yu Y, Xue H, Suo C, Wang H, Pang Y, Ji C, Hou W, Lu Y, Lu D, Sang L, Xu J, Li C, Jin L, Shi L, Zhang J, Liang J, Zhao W, Chen X. Palliative Care Educational App for Family Caregivers of Homebound Patients With Incurable Cancer : A Single-Center Randomized Trial. Ann Intern Med. 2025 Dec;178(12):1737-1751. doi: 10.7326/ANNALS-25-02346. Epub 2025 Sep 23.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KSBU-MHEALTH-PC-2026-01
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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