Implementation and Testing of an eHealth Integrated Model of Care for Patients Receiving Allogeneic Stem Cell Transplantation: The SMILe Project

NCT04789863 | Completed

• 1 other identifier: SMILe
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous publications call for innovation based on integrated care principles, investment in self-management and use of eHealth to improve outcomes for allogeneic Stem Cell Transplant (alloSCT). While eHealth supported integrated care models are effective, real-world implementation remain elusive. The newly developed SMILe-Integrated Care Model (ICM) is the first theory-based eHealth supported integrated care model for alloSCT patients. SMILe-ICM includes four self-management modules (i.e., monitoring \& follow-up, medication adherence, infection prevention, physical activity) and combines a human role, i.e., a Care Coordinator (CC), with a technological component (i.e., the SMILeApp). Patients monitor and transfer symptoms and health behaviours to their CC, who supports them in self-management and dealing with complications. Embedded in implementation science methodology, we aim to implement and test the SMILe-ICM at the University Hospital Basel (USB) in the first year post-alloSCT by evaluating effectiveness, implementation outcomes and implementation pathway. A hybrid 1 effectiveness-implementation randomized controlled trial will include 80 adult alloSCT patients who are transplanted and followed up at USB, have basic German proficiency and provide written informed consent. Patients with physical or mental conditions limiting the use of the SMILeApp will be excluded. About ten days before alloSCT, a stratified randomization based on participants' clinical risk scores will assign patients 1:1 to the control (CG) or intervention group (IG). The CG will receive usual care; the IG will receive the SMILe-ICM over one year with 12 CC visits and continuous use of the SMILeApp. Re-hospitalization rate (primary outcome), total healthcare utilization costs, acute and chronic GvHD episodes and survival will be assessed using medical records. Medication adherence will be assessed via the BAASIS© scale, treatment burden via the PETS©, health-related quality of life via the EQ-5D-5L©. Implementation outcomes will be assessed via questionnaires and the implementation pathway via qualitative focus groups, each from patient and CC perspectives. Patients will be followed up 3 months after the intervention ended. Intention-to-treat and per-protocol analyses will be conducted using the rate ratio by unconditional maximum likelihood estimation (Wald) for the primary outcome. Qualitative data will be analysed using mind-mapping techniques and thematic analysis.

Conditions

Stem Cell Transplantation

Keywords

Implementation Science; Delivery of Health Care, Integrated; Telemedicine; Advanced Practice Nursing; Randomized Controlled Trial; Self-Management

Outcome Measures

Primary Outcomes (1)

• Change of re-hospitalization rate from post-alloSCT discharge up to 15 months after allogeneic stem cell transplantation

  The number of events after the initial post-alloSCT discharge per patient

  Data will be collected monthly via medical records during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.

Secondary Outcomes (10)

• Change of total healthcare utilization costs from post-alloSCT discharge until 15 months post-alloSCT

  Data will be collected monthly during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.

• Change of medication adherence from post-alloSCT discharge until 15 months post-alloSCT

  Data will be collected monthly (BAASIS©) and daily (MEMS® Button) during the study period as long as patients need to take immunosuppressants, i.e., at the longest until 1 year post-alloSCT and for a further period of 3 months.

• Change of treatment burden from baseline until 12 months post-alloSCT

  Data will be collected at baseline, days +90, +180 and +365 via self-report questionnaire (PETS©) during the intervention period.

• Change of HRQL from baseline until 12 months post-alloSCT

  Data will be collected monthly via medical records during the intervention period, i.e., until one year post-alloSCT.

• Change of QALY from baseline until 12 months post-alloSCT

  Data will be collected monthly during the intervention period, i.e., until one year post-alloSCT.

Study Arms (2)

Intervention group

OTHER

Intervention group (IG) patients will receive usual care plus the SMILe-ICM (see below) when they come to their planned follow-up appointments at the University Hospital Basel. Thus, while IG participants will receive the same number of follow-up appointments as CG participants (depending on their state of health), they will also receive the SMILe-ICM, i.e., tailored self-management and behavioural support delivered by the combination of totally 12 face-to-face meetings with a Care Coordinator (CC) and the SMILeApp. The personal meetings with the CC will last around 40-90 minutes. The first three of them will occur during the initial alloSCT hospitalization, and the other nine will occur in the outpatient setting, beginning with biweekly and expanding to bi-monthly intervals until one year post-alloSCT.

Device: SMILe-Integrated Care Model

Control group

OTHER

see "Intervention" section

Other: Usual Care

Interventions

SMILe-Integrated Care Model DEVICE

Four self-management intervention modules will be delivered by human and technology: 1) monitoring \& follow-up; 2) infection prevention; 3) medication adherence; 4) physical activity. Human. A CC will provide structured and tailored self-management and behavioural support regarding all 4 modules via 12 face-to-face meetings congruent with planned clinic follow-up visits. The CC will be connected with the patients via the SMILe technology, enabling rapid responses to early signs of health deterioration. Technology. The SMILe technology consists of the SMILeApp and SMILeCare. The latter is the interface of the monitoring component to connect the patient with the CC supporting fast recognition of symptoms and health deterioration. The SMILeApp enables to daily record a set of medical, behavioural and symptom-related data. A lexicon provides self-management and behavioural information. All data will be transferred to the clinic to be monitored, with the patient's consent, via SMILeCare.

Intervention group

Usual Care OTHER

The control group (CG) participants will receive usual care, which includes no specific counselling. USB outpatient appointment frequency follows a standard schedule: during the first 3 months post-alloSCT, depending on their health status, most patients (73%) return 1 to 3 times per week for follow-up at the USB outpatient clinic, where they are mainly seen by a junior or senior physician. Depending on health status and recovery, follow-up intervals extend to weekly or monthly within 1 year post-alloSCT. A research assistant (RA) will just contact CG participants for data collection. If participants raise concerns about any symptoms, the RA will encourage them to contact their physicians.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's allogeneic stem cell transplantation and follow-up treatment is planned at the University Hospital Basel
• Aged ≥ 18 years
• Able to speak, read and write German at least limited working proficiency (i.e., to satisfy conversations and understand written material regarding routine social demands and limited requirements)
• Able to plan and perform self- management activities independently
• WLAN access at home or own a sufficient mobile data contract
• Normal, mental, physical and psychological abilities and health to provide a written informed consent about study participation and related data protection

You may not qualify if:

• General condition make self-management impossible for more than 4 weeks
• Follow up care solely at an external center
• Diagnosed with dementia
• A second allogeneic stem cell transplantation becomes necessary

Sponsors & Collaborators

• University of Basel: lead
• University Hospital Freiburg: collaborator
• University Hospital, Basel, Switzerland: collaborator
• University of Applied Science Augsburg, Germany: collaborator
• KU Leuven: collaborator
• University Hospital, Zürich: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

University Hospital Basel

Basel, Basel, 4056, Switzerland

Location

Related Publications (1)

• De Geest S, Valenta S, Ribaut J, Gerull S, Mielke J, Simon M, Bartakova J, Kaier K, Eckstein J, Leppla L, Teynor A; SMILe team. The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial. BMC Health Serv Res. 2022 Aug 20;22(1):1067. doi: 10.1186/s12913-022-08293-8.

  PMID: 35987671 DERIVED

Study Officials

• Sabine De Geest, Prof.

  Nursing Science, Department Public Health, University of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.; PhD, RN, FAAN, FRCN, FEANS

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)