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Trial record 61 of 137 for:    Recruiting, Not yet recruiting, Available Studies | "Pituitary Diseases"

Development and Validation of a Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency (GrASS)

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ClinicalTrials.gov Identifier: NCT03525587
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena

Brief Summary:

Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers concerning patient-clinician communication, inadequate patients' awareness of the disease, low perceived benefit of replacement therapy and poor compliance still remains.

The overall goal of the study is to improve AGHD management through a Smartphone app (MAGHD App: Manage Adult Growth Hormone Deficiency) integrated with a software framework able to merge patients daily data on physical activity, quality of life (QoL), and well-being with clinical data collected in institutional databases. The target population consists of 100 patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not.

In a prospective 24 months study, MAGHD App will be developed and connected to MAGHD Framework. This system will allow to integrate: 1) Physical Activity Data collected by wearable devices, 2) Patient Related Outcomes Data, periodically inserted by the patients through MAGHD App in response to questions extrapolated from validated questionnaires, 3) HCP Data registered in clinical databases and including medical history, biochemical and radiological examination. Data will converge in MAGHD Framework where they will be analyzed and used to create reports visible to patients (in MAGHD App) and clinicians (by a monitoring dashboard).

The results are expected to positively influence AGHD management by involving patients in care process and giving clinicians a useful tool for clinical practice.


Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Other: Use of "MAGHD App/MAGHD Framework" Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Patients with a previous documented AGHD fitting the inclusion/exclusion criteria will be enrolled and grouped as follows:

  • Group 1: patients on long-term r-hGH therapy;
  • Group 2: patients previously treated with r-hGH, who had stopped the treatment for any reason (age, concomitant adverse reactions, contraindications or personal will);
  • Group 3: patients never treated for any reason (according to age, contraindications or lack of patient's consent).

The whole cohort of AGHD patients (n=100) will undergo 2 consecutive phases: in the first phase (12 months) patients will be evaluated as usual every six months according to our standard clinical practice without using the App and the wearable device (baseline visit, visit 1 and visit 2), while in the second phase (following 12 months) they will be evaluated every six months during the use of the App (visit 3 and visit 4).

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development and Validation of a Novel Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency (MAGHD App): a Single-Centre Model. GrASS (Growth Hormone Deficiency in Adults Self-assessment System)
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : November 30, 2020


Arm Intervention/treatment
Active Comparator: Ongoing r-hGH therapy

Patients on long-term r-hGH therapy.

Intervention: Use of "MAGHD App/MAGHD Framework"

Other: Use of "MAGHD App/MAGHD Framework"
Patients daily related outcomes will be recorded thanks to the development, implementation and validation of a Smartphone app (MAGHD App) integrated with a software framework able to merge patient's daily activities data on well-being status, QoL, physical activities and sexual function with clinical data collected in their record chart (extrapolated from already available Institutional Databases).

Active Comparator: Previous r-hGH therapy

Patients previously treated with r-hGH, who had stopped the treatment for any reason (age, concomitant adverse reactions, contraindications or personal will).

Intervention: Use of "MAGHD App/MAGHD Framework"

Other: Use of "MAGHD App/MAGHD Framework"
Patients daily related outcomes will be recorded thanks to the development, implementation and validation of a Smartphone app (MAGHD App) integrated with a software framework able to merge patient's daily activities data on well-being status, QoL, physical activities and sexual function with clinical data collected in their record chart (extrapolated from already available Institutional Databases).

Active Comparator: Never treated

Patients never treated for any reason (according to age, contraindications or lack of patient's consent).

Intervention: Use of "MAGHD App/MAGHD Framework"

Other: Use of "MAGHD App/MAGHD Framework"
Patients daily related outcomes will be recorded thanks to the development, implementation and validation of a Smartphone app (MAGHD App) integrated with a software framework able to merge patient's daily activities data on well-being status, QoL, physical activities and sexual function with clinical data collected in their record chart (extrapolated from already available Institutional Databases).




Primary Outcome Measures :
  1. Changes of quality of life (QoL) from baseline [ Time Frame: 24 months ]
    Comparison of changes of QoL score from baseline for each patient within the three different groups. QoL score will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.


Secondary Outcome Measures :
  1. Changes of well-being from baseline [ Time Frame: 24 months ]
    Comparison of changes of Well-being score from baseline for each patient within the three different groups. Well-being score will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  2. Changes of physical activity from baseline [ Time Frame: 24 months ]
    Comparison of changes of physical activity score from baseline for each patient within the three different groups. Physical activity score will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  3. Changes of sleep quality from baseline [ Time Frame: 24 months ]
    Comparison of changes of sleep quality score from baseline for each patient within the three different groups. Sleep quality score will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  4. Changes of sexual function from baseline [ Time Frame: 24 months ]
    Comparison of changes of sexual function scores (IIEF-5 score for men and FSFI score for woman) from baseline for each patient within the three different groups. Sexual function scores will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  5. Changes of insulin-like growth factor 1 (IGF-1) levels from baseline [ Time Frame: 24 months ]
    Comparison of changes of IGF-1 levels from baseline for each patient within the three different groups. IGF-1 levels will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  6. Changes of lipid profile from baseline [ Time Frame: 24 months ]
    Comparison of changes of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides from baseline for each patient within the three different groups. Lipid profile will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  7. Changes of body composition from baseline [ Time Frame: 24 months ]
    Comparison of changes of % of lean mass and fat mass from baseline for each patient within the three different groups. Body composition will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  8. Changes of bone mineral density from baseline [ Time Frame: 24 months ]
    Comparison of changes of T-score at lumbar site and at femoral site from baseline for each patient within the three different groups. Bone mineral density will be evaluated and compared before and after the use of the integrated system MAGHD App/MAGHD Framework.

  9. Adherence to r-hGH therapy (average number of weekly forgetfulnesses) [ Time Frame: 24 months ]

    Evaluation of possible changes in adherence to r-hGH therapy (only in patients of Group 1) from Phase 1 and Phase 2.

    Average number of weekly forgetfulnesses of r-hGH therapy will be considered to verify the adherence to therapy.


  10. Impact of physical activity on BMI [ Time Frame: 12 months ]
    Evaluation of the impact of physical activity in AGHD patients (as recorded by the MAGHD App in Phase 2) on BMI. Weight and height will be combined to report BMI in kg/m^2.

  11. Impact of physical activity on body composition [ Time Frame: 12 months ]
    Evaluation of the impact of physical activity in AGHD patients (as recorded by the MAGHD App in Phase 2) on body composition (% of lean mass and fat mass).

  12. Impact of physical activity on lipid profile [ Time Frame: 12 months ]
    Evaluation of the impact of physical activity in AGHD patients (as recorded by the MAGHD App in Phase 2) on lipid profile (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides).

  13. User's satisfaction about MAGHD App [ Time Frame: 12 months ]
    Evaluation of user's satisfaction about MAGHD App through the number of messages the user has returned in response to the questions of each questionnaire he received. The App will record the number of the user answers as well as the missing ones. For each patient will be considered the following ratio: number of returned messeges/total number of sent messages.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Having a documented diagnosis of AGHD, according to the latest Endocrine Society clinical practice guidelines
  2. Being at least 18 years old
  3. Having a good Italian understanding
  4. Owing smartphones with either an Android or iPhone operating system
  5. Patients with other pituitary deficits will be enrolled only if the other hormonal deficiencies are well controlled by replacement treatments since six months in order to avoid the overlap of effects due to different therapies.

Exclusion Criteria:

1) Patients who do not plan to continue follow-up at the Endocrinology Unit of Modena 2) Patients with a diagnosis of biochemical GHD outside the appropriate clinical context of pituitary disease 3) Patients with major psychiatric diseases, chronic highly invalidating diseases (these patients will be considered not eligible for being enrolled in the study due to the impact of the underlying disease on well-being and daily activities).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525587


Contacts
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Contact: Vincenzo Rochira, Professor +390593962453 vincenzo.rochira@unimore.it
Contact: Chiara Diazzi, PhD +390593961816 chiaradiazzi@gmail.com

Locations
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Italy
Azienda Ospedaliero - Universitaria di Modena Recruiting
Modena, Italy, 41124
Contact: Vincenzo Rochira, Professor    +390593962453    vincenzo.rochira@unimore.it   
Contact: Chiara Diazzi, PhD    +39059-3961816    chiaradiazzi@gmail.com   
Principal Investigator: Vincenzo Rochira, Professor         
Sub-Investigator: Chiara Diazzi, PhD         
Sub-Investigator: Elisa Magnani, MD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
Pfizer
Investigators
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Principal Investigator: Vincenzo Rochira, Professor Azienda Ospedaliero-Universitaria di Modena

Publications:

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Responsible Party: Vincenzo Rochira, MD, PhD - Associate Professor of Endocrinology, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT03525587     History of Changes
Other Study ID Numbers: 346/17
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The University of Modena and Reggio Emilia and the P.I. are the owners of the study data, which will be available for DataRiver for the results' analysis. The project will be disseminated through publication on indexed international journals and will be evaluated by number of papers/citations received in scientific and academic context. Preliminary results will be shown at National and International congresses.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena:
Quality Improvement
Quality of Life
Smartphone APP
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Pituitary Diseases
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs