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A Pilot Trial of a Smartphone-based Self-management Support Program for COPD Patients

11 aprile 2022 aggiornato da: Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong

A Pilot Trial of a Smartphone-based Self-management Support Program for Patients With Chronic Obstructive Pulmonary Disease

COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

The current proposal is to evaluate the feasibility and acceptability of a pilot trial of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Chronic obstructive pulmonary disease (COPD) is the number 3 killer globally by 2020. COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

Current policy for the prevention and management of long-term conditions focuses on efforts to prevent the onset or slow progression of disease early in the disease trajectory. This prevention paradigm has only recently been adopted for COPD. Systematic reviews have shown self-management support for patients with COPD is effective in improving health-related quality of life and in reducing hospital admissions, but the evidence comes largely from patients with moderate or severe disease and is predominantly recruited from secondary care. Simple and systematic strategies are needed to improve out-of-hospital support and management for people living with COPD.

An instant messaging smartphone app, which allows texts, audio, pictures and video messages to be shared in chat groups, is already available to and is the most popular in the Hong Kong general public. Mobile instant messaging can be conducted through a daily use device to increase access and efficacy, which has been suggested as a feasible approach to delivering an intervention with positive effects on health behaviours and outcomes. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change in diabetes self-management, weight loss, physical activity, smoking cessation and medication adherence with quantitative and qualitative evidence. However, the investigator has not found messaging intervention that was applied in people with COPD, except an ongoing study of using instant text message support for patients with chronic respiratory and cardiovascular diseases.

Hence, the current intervention program is to evaluate the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

14

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Asa Choi, MA
  • Numero di telefono: 852-3917-6563
  • Email: asachoi@hku.hk

Backup dei contatti dello studio

  • Nome: Agnes YK Lai, PhD
  • Numero di telefono: 852-3917-6328
  • Email: agneslai@hku.hk

Luoghi di studio

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Reclutamento
        • Queen Mary Hospital
        • Contatto:
          • David Lam, PhD
          • Numero di telefono: 2255-4455
          • Email: slnga@hku.hk
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria

  • Aged 18 years and above
  • Diagnosis with COPD
  • General condition stable
  • Able to speak and read Chinese
  • Able to complete the self-administered questionnaire
  • Able to use instant messages such as WhatsApp or WeChat
  • Mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator
  • Signed informed consent

Exclusion criteria

  • Skeletal fragility
  • Serious active infection
  • Inability to walk
  • Severe respiratory insufficiency

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group
The intervention group will receive a smartphone-based self-management support programme, including a 30-min face-to-face or online session at baseline, 3 phone calls (week 2, week 4 and week 6) and 2-month mobile messages in addition to usual care.
Comportamentale: Self-management and Support
A smartphone-based self-management support programme includes a 30-min face-to-face or online session at baseline, 3 phone calls and 2-month mobile messages

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline COPD-related quality of life
Lasso di tempo: Baseline, Week 8
COPD symptoms and impacts and activity level were measured by an 8-item COPD Assessment Test. Total scores range from 0 to 40, with higher scores denoting a more severe impact of COPD on a patient's life.
Baseline, Week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline patient activation
Lasso di tempo: Baseline, Week 8
Knowledge, skills and confidence in self-management were measured by a 13-item Patient Activation Measure Scale. The total score ranges from 0 (no activation) to 100 (high activation), with higher scores denoting the better patient activation.
Baseline, Week 8
Change from baseline self-efficacy for self-management
Lasso di tempo: Baseline, Week 8
Confidence and perceived ability of self-care were measured by a 6-item Stanford self-efficacy scale. The score for each item ranges from 1 (not at all confident) to 10 (totally confident). The total score of the scale is the mean of the six items, with higher number indicates higher self-efficacy.
Baseline, Week 8
Change from baseline acceptance of illness
Lasso di tempo: Baseline, Week 8
Acceptance of illness measured by a 8-item acceptance of illness scale. Each item ranges from 1 to 5. The total score of the scale is between 8 and 40, with low score showing a lack of adjustment to the disease, no acceptance of the condition, and mental discomfort, while high score indicating good disease acceptance.
Baseline, Week 8
Change from baseline medication adherence
Lasso di tempo: Baseline, Week 8
Medication adherence measured by a 4-item Morisky Medication-Taking Adherence Scale. The scale consists of four items with a scoring scheme of "Yes" = 0 and "No" = 1. All items are summed to give a range of scores from 0 to 4, with higher score indicating a low level of medication adherence.
Baseline, Week 8
Change from baseline physical activity level
Lasso di tempo: Baseline, Week 8
Physical activity measured by a 7-item International Physical Activity Questionnaire-short form. Number of days and duration (in hours and minutes) engaging in vigorous activities, moderate activities, and walking in past 7 days will be collected. Duration (in hours and minutes) of sitting time on week days and weekends will be collected.
Baseline, Week 8
Change from dyspnea severity
Lasso di tempo: Baseline, week 8
Dyspnea severity measured by a 1-item MRC dyspnea scale. The scale consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house". Patients selected the grade that applied to them.
Baseline, week 8
Change from baseline Health status
Lasso di tempo: Baseline, Week 8
Health status measured by a 5-item EuroQol 5-Dimension questionnaire. The scale comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was scored by five levels, with 1 representing no problem and 5 representing extreme problem.
Baseline, Week 8
Change from anxiety and depressive symptoms
Lasso di tempo: Baseline, Week 8
Anxiety and depressive symptoms measured by a 14-item Hospital Anxiety and Depression Scale. Each item ranges from 0-3. The total scores of both Anxiety and Depression subscales range from 0-21, with higher scores indicating higher level of anxiety and depression respectively.
Baseline, Week 8
Change in baseline social support
Lasso di tempo: Baseline, Week 8
Social support measured by a 6-item Multidimensional Scale of Perceived Social Support. Each item ranges from 1 (very strongly disagree) to 7 (very strongly agree). The total score is the sum across all items divided by 6, with higher score indicating more social support.
Baseline, Week 8
Change in from baseline sleep quality
Lasso di tempo: Baseline, Week 8
Sleep quality measured by a 7-item Insomnia Severity Index. The total score range from 0 (absence of insomnia) to 28 (severe insomnia).
Baseline, Week 8
Change in baseline grip strength
Lasso di tempo: Baseline, Week 8
Grip strength of both hands measured by dynamometer
Baseline, Week 8
Change in baseline balance
Lasso di tempo: Baseline, Week 8
Balance assessed by a single-leg stance test.
Baseline, Week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Hong Kong

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 gennaio 2022

Completamento primario (Anticipato)

31 maggio 2022

Completamento dello studio (Anticipato)

31 maggio 2022

Date di iscrizione allo studio

Primo inviato

27 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

13 gennaio 2022

Primo Inserito (Effettivo)

14 gennaio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UW21-532-2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Need to obtain consent from patients before agreeing to share individual participants data.

Periodo di condivisione IPD

When study finished

Criteri di accesso alla condivisione IPD

The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Asa Choi (email asachoi@hku.hk), (School of Nursing, The University of Hong Kong) for further information.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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