Frailty Clinical Trial
— SAVEOfficial title:
A Technology-based Intervention to Support Older Adults in Living Independently: Protocol for a Cross-national Feasibility Pilot
Verified date | November 2022 |
Source | Istituto Nazionale di Ricovero e Cura per Anziani |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The general objective of this study is to test the usability and efficiency of the SAVE prototype, a technology-based support for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Mini Mental State Evaluation (MMSE) between 21 and 24 - Healthy or mild to moderate chronic illness or musculoskeletal disease - Feel physically fit to participate in the study Exclusion Criteria: - Participants suffer from severe chronic disease |
Country | Name | City | State |
---|---|---|---|
Hungary | Országos Orvosi Rehabilitációs Intézet, Szanatórium | Budapest | |
Italy | IRCCS INRCA Hospital | Ancona | |
Romania | Transilvania University of Bra?ov | Bra?ov |
Lead Sponsor | Collaborator |
---|---|
Istituto Nazionale di Ricovero e Cura per Anziani | European Union |
Hungary, Italy, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Usability | This outcome will be measured through the System Usability Scale (SUS). It consists of a 10-item questionnaire with five response options for respondents from 'Strongly agree' to 'Strongly disagree'. | Change from baseline SUS at 21 days from the start of the intervention | |
Primary | Acceptance | This outcome will be measured through the the User Experience Questionnaire (UEQ). The UEQ is a semantic differential with 26 items. The scales of the questionnaire cover a comprehensive impression of user experience. Items are scored on a 7-point Likert scale and range from full agreement with the negative term (-3) to the full agreement with the positive term (+3). Half of the items start with the positive term, the rest with the negative term. Higher sum scores indicate more positive evaluation. | Change from baseline UEQ at 21 days from the start of the intervention | |
Secondary | Cognitive impairment | This outcome will be measured by Mini-Mental State Examination (MMSE). It is a neuropsychological test for the evaluation of disorders of intellectual efficiency and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 26 to 30 is an indication of cognitive normality. The score will be adjusted with the coefficient for age and schooling. | at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention | |
Secondary | Autonomy in walking | This outcome will be measured by the Ambulation Category (FAC). It is a scale that evaluates the ability to autonomy in walking. The ambulatory capacity is evaluated with a score ranging from 0 to 5, where 0 indicates total dependence and 5 complete autonomy. | at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention | |
Secondary | Functional status | This outcome will be measured by the Barthel Index. The individual is scored in a number of areas depending upon independence of performance. Total scores range from 0 (complete dependence) to 100 (complete independence). | at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention | |
Secondary | State of health | This outcome will be measured by the SF-12v2 ™ Health Survey. It is a widely used instrument, and is a 12-element sub-set of the SF-36v2™. This is a generic assessment of the health-related quality of life from the patient's perspective. The mean score is set to 50. Scores >50 indicate better physical or mental health than the mean. Scores <50 indicate worse physical or mental health than the mean. | at baseline, at 10 days from the start of the intervention and at 21 days from the start of the intervention |
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