The mHTX APP Program

NCT07813416 | Enrolling By Invitation

• 1 other identifier: HTXAUHRH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Current Danish studies emphasize the importance of better integrated and efficient lifelong health care to heart-transplant recipients regardless of socioeconomic position. Our objective is to design and evaluate a new digital patient-centered and socially differentiated program after heart transplantation in Denmark. Investigators use a participatory approach with involvement of users: 1) Design phase: Mobile health app; Patient-reported outcomes; Case manager function, 2) Feasibility Study with 25 recipients and process evaluation within 1 month, 3) Randomized Study, including 200 recipients followed for 1 year. Effectiveness is measured as cross-sectional care utilization; costs; events. Efficacy is measured as adherence to pharmacotherapies, labor market participation, and quality of care. Nationwide registers will be linked with interview data, surveys, and app login. This digital transformation of cross-sectional care after heart transplantation will facilitate equality in health.

Conditions

Rehabilitation; Follow up

Keywords

Heart Transplantation; Life-long health care; mHealth; Patient-Reported Outcomes; Case managers; Social differentiation

Outcome Measures

Primary Outcomes (1)

• The primary outcome is reduced hospitalization

  From the Danish National Patient Registry (DNPR), investigators will obtain information on total in-hospital activity (all admissions and outpatient dates) and sum up.

  Within one year after index date

Secondary Outcomes (10)

• Medical therapies

  Within one year after index date

• General practice activity

  Within one year after index date

• Health care costs

  Within one year after index date

• Adverse events

  Within one year after index date

• Adherence to recommended pharmacotherapies

  Within one year after index date

Other Outcomes (1)

• Efficacy explorative

  Efficacy explorative will be assessed within one year after index date.

Study Arms (2)

Control group:

NO INTERVENTION

Usual care with recommended long-term multidisciplinary and cross-sectional management after HTX (n=100).

Intervention group

ACTIVE COMPARATOR

The new and feasible mHTx APP Program in the setting of usual recommended long-term multidisciplinary and cross-sectional management after HTX (n=100)

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

* mHealth care and App platform: Information modules and videos, self-monitoring, reminder, chat function, cross-sectional health care plan, and appointment overview.1 * ePROs: National heart failure (HF) PRO (health experience), BAASIS scale (The Basel Assessment of Adherence to immunosuppressive medications Scale), PACIC score (Patient Assessment of Chronic Illness Care), Multimorbidity Treatment Burden (MTBQ). * Case manager function: Support patient-centered and socially differentiated health care planning 13 using the mHTX App as well as help with App functionality.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Recipients are eligible if they are ≥18 years and not terminal.

You may not qualify if:

• Recipients who do not own and use an Android or Apple smartphone or are unable to understand Danish will be excluded.

Sponsors & Collaborators

• University of Aarhus: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (15)

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  PMID: 31372058 BACKGROUND

• Leask CF, Sandlund M, Skelton DA, Altenburg TM, Cardon G, Chinapaw MJM, De Bourdeaudhuij I, Verloigne M, Chastin SFM; GrandStand, Safe Step and Teenage Girls on the Move Research Groups. Framework, principles and recommendations for utilising participatory methodologies in the co-creation and evaluation of public health interventions. Res Involv Engagem. 2019 Jan 9;5:2. doi: 10.1186/s40900-018-0136-9. eCollection 2019.

  PMID: 30652027 BACKGROUND

• Ortenblad L, Meillier L, Jonsson AR. Multi-morbidity: A patient perspective on navigating the health care system and everyday life. Chronic Illn. 2018 Dec;14(4):271-282. doi: 10.1177/1742395317731607. Epub 2017 Sep 15.

  PMID: 28914088 BACKGROUND

• Coleman K, Austin BT, Brach C, Wagner EH. Evidence on the Chronic Care Model in the new millennium. Health Aff (Millwood). 2009 Jan-Feb;28(1):75-85. doi: 10.1377/hlthaff.28.1.75.

  PMID: 19124857 BACKGROUND

• Moons P, Norekval TM, Arbelo E, Borregaard B, Casadei B, Cosyns B, Cowie MR, Fitzsimons D, Fraser AG, Jaarsma T, Kirchhof P, Mauri J, Mindham R, Sanders J, Schiele F, Torbica A, Zwisler AD. Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management. Eur Heart J. 2023 Sep 21;44(36):3405-3422. doi: 10.1093/eurheartj/ehad514.

  PMID: 37606064 BACKGROUND

• Killian MO, Schelbe L, Lustria MLA, Watkivs M, Gupta D. Engaging Adolescent Heart Transplant Recipients Through In-App Messaging During Mobile Health Intervention. Prog Transplant. 2023 Sep;33(3):229-235. doi: 10.1177/15269248231189862. Epub 2023 Jul 25.

  PMID: 37491864 BACKGROUND

• Gomis-Pastor M, Mirabet Perez S, De Dios Lopez A, Brossa Loidi V, Lopez Lopez L, Pelegrin Cruz R, Mangues Bafalluy MA. Does an eHealth Intervention Reduce Complications and Healthcare Resources? A mHeart Single-Center Randomized-Controlled Trial. J Cardiovasc Dev Dis. 2023 Feb 10;10(2):77. doi: 10.3390/jcdd10020077.

  PMID: 36826572 BACKGROUND

• Mols RE, Bakos I, Logstrup BB, Horvath-Puho E, Gustafsson F, Eiskjaer H. Adherence to Pharmacotherapies After Heart Transplantation in Relation to Multimorbidity and Socioeconomic Position: A Nationwide Register-Based Study. Transpl Int. 2023 Oct 11;36:11676. doi: 10.3389/ti.2023.11676. eCollection 2023.

  PMID: 37885807 BACKGROUND

• Bezerra Giordan L, Tong HL, Atherton JJ, Ronto R, Chau J, Kaye D, Shaw T, Chow C, Laranjo L. The Use of Mobile Apps for Heart Failure Self-management: Systematic Review of Experimental and Qualitative Studies. JMIR Cardio. 2022 Mar 31;6(1):e33839. doi: 10.2196/33839.

  PMID: 35357311 BACKGROUND

• Fleming JN, Pollock MD, Taber DJ, McGillicuddy JW, Diamantidis CJ, Docherty SL, Chambers ET. Review and Evaluation of mHealth Apps in Solid Organ Transplantation: Past, Present, and Future. Transplant Direct. 2022 Feb 21;8(3):e1298. doi: 10.1097/TXD.0000000000001298. eCollection 2022 Mar.

  PMID: 35368987 BACKGROUND

• Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.

  PMID: 34593508 BACKGROUND

• Kristiansen AM, Lonnberg H, Christensen B, Bridal Logstrup B, Eiskjaer H, Terkildsen Maindal H, Elmose Mols R. Experiences with cross-sectional healthcare and treatment in heart failure patients: implications for medical education. Int J Med Educ. 2022 Dec 30;13:345-362. doi: 10.5116/ijme.6399.eef4.

  PMID: 36587398 BACKGROUND

• Mols RE, Logstrup BB, Bakos I, Horvath-Puho E, Christensen B, Witt CT, Schmidt M, Gustafsson F, Eiskjaer H. Individual-Level Socioeconomic Position and Long-Term Prognosis in Danish Heart-Transplant Recipients. Transpl Int. 2023 Mar 22;36:10976. doi: 10.3389/ti.2023.10976. eCollection 2023.

  PMID: 37035105 BACKGROUND

• Mols RE, Bakos I, Christensen B, Horvath-Puho E, Logstrup BB, Eiskjaer H. Influence of multimorbidity and socioeconomic factors on long-term cross-sectional health care service utilization in heart transplant recipients: A Danish cohort study. J Heart Lung Transplant. 2022 Apr;41(4):527-537. doi: 10.1016/j.healun.2022.01.006. Epub 2022 Jan 10.

  PMID: 35101340 BACKGROUND

• Velleca A, Shullo MA, Dhital K, Azeka E, Colvin M, DePasquale E, Farrero M, Garcia-Guereta L, Jamero G, Khush K, Lavee J, Pouch S, Patel J, Michaud CJ, Shullo MA, Schubert S, Angelini A, Carlos L, Mirabet S, Patel J, Pham M, Urschel S, Kim KH, Miyamoto S, Chih S, Daly K, Grossi P, Jennings DL, Kim IC, Lim HS, Miller T, Potena L, Velleca A, Eisen H, Bellumkonda L, Danziger-Isakov L, Dobbels F, Harkess M, Kim D, Lyster H, Peled Y, Reinhardt Z. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023 May;42(5):e1-e141. doi: 10.1016/j.healun.2022.10.015. Epub 2022 Dec 20. No abstract available.

  PMID: 37080658 BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After obtaining written informed consent (index date), recipients will be randomized (non-blinded) through a computer-generated 1:1 ratio (REDCap) stratified by age and gender to either Intervention group or Control group

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 10, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-08

Locations

DK (1)