SOW_for_PROMISS_Study.pdf

STATEMENT OF WORK, September 2018

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Medical Test Services in PROMISS Task 2.2

Statement of Need and Purpose:

The need is to understand energy expenditure in frail malnourished older persons. In general, studies of nutrition and its consequences in old age have included primarily high functioning, fairly healthy older people. The opportunity to assess frail older persons, such as those participating in this study, will provide important new scientific information. The University of Southern Denmark is part of a large consortium of institutions across Europe (PROMISS) that are involved in assessment of malnutrition in older persons and a study of its consequences.

One of the key parameters being studied as part of the PROMISS Study is movement in daily life recorded by an accelerometer monitor that is worn on the wrist and on the waist. In order to calibrate the various instruments used across the partner studies in the parent EU-funded study, the University of Southern Denmark is funded to carry out a detailed study of the utility of various monitor types, the best wear position for these monitors, and what effect there might be resulting from malnutrition. Their goal is to establish a range of measures common in the study of old age and to assess the association of these measures and nutritional status with accelerometer-derived measures.

The purpose of the study is therefore to measure energy expenditure in a free-living environment for the participants in the PROMISS Study Task 2.2, a methodological study composed of a laboratory examination day and a two-week measurement period in free-living conditions, comparing 50 well-nourished and 50 malnourished Danish men and women aged 80+ years. This measurement will allow calibration of accelerometry instruments across populations. Many measurements are already included in the study; however several key measurements are not. Key missing measurements include a medical assessment and laboratory testing of nutritional status, and a measurement of body composition relating to maintenance of protein store over time. The desired result would be to have these additional measurements collected on all participants.

Background Information and Objective:

In Europe, about 21% of older adults are malnourished or at risk of malnourishment. Inadequate nutritional intake (particularly protein) in old age could be the first step leading to a downward spiral of adverse health events (including loss of muscle mass, increased fatigue, loss of function etc.) and potentially have a detrimental effect on the quality of life of older adults. It is hypothesized that malnourished older adults have lower level of muscle mass, perform worse in functional tasks, and may have different daily physical activity patterns (e.g. higher amount of sedentary behavior, take longer and more frequent naps) when compared to their well-nourished counterparts. From a public health perspective, it is important to first identify the difference in physical activity pattern between well-nourished and malnourished individuals in order to design adequate strategies that help this population to achieve the recommended daily physical activity level. More knowledge in this area is needed for deeper understanding and accurate interpretation of the collected accelerometer data. In addition, the possibility to interpret data from studies using different accelerometers and accelerometers set-ups on different anatomical locations is highly challenging. Thus, different accelerometry set-up may challenge the interpretation of health-enhancing effects of physical activity and detrimental effects of sedentary behavior simply because of a methodologic issue, hence the need for the energy expenditure studies.

This study is part of a larger European research project entitled “PROMISS (Prevention Of Malnutrition in Senior Subjects in the EU)”, a multi-country project aiming to turn the challenge of tackling malnutrition in community-dwelling older persons into an opportunity for healthy ageing for the future. The project was financed under the European research program Horizon 2020 (http://www.promiss-vu.eu/). The aim of PROMISS work package 2 is to examine daily physical activity and sedentary behaviour patterns among older Europeans.

To ensure a consistent interpretation of accelerometry data in older adults across different strata of malnutrition, we propose this methodological study in both laboratory and free-living conditions to examine how to translate between each accelerometer and energy expenditure, and which accelerometer performs best.

In this methodological study of normally nourished and malnourished participants, reseachers at the University of Southern Denmark will determine comparability among instruments. To enhance this study we will add three sets of measurements to the study: a medical screening and a set of laboratory tests which will allow us to better determine nutritional status, and a dual energy x-ray absorptiometry (DXA) measurement which will help us to determine how body composition affects malnutrition.

Period of Performance:

One year from date of award.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government.

The contractor shall conduct the following as part of the study of accelerometry and nutritional status:

1. A medical screening of participants in the study which will focus on malnutrition and the ability of the participant to take part in the study

2. A set of laboratory tests focused primarily on malnutrition

3. Dual energy x-ray absorptiometry

Specific Requirements:

1. Medical screening of participants in the study which will focus on malnutrition and the ability of the participant to take part in the study.

http://www.promiss-vu.eu/

This will involve a checking of major organ systems with an eye to understanding whether frailer older persons can effectively participate in the larger study comparing accelerometers. It is of interest to our group what measures are useful in defining frailty and how these can be combined with measures already planned, such as dietary patterns, to assess malnutrition.

2. Set of laboratory tests focused primarily on malnutrition.

This is meant primarily to augment the medical screening as it is possible that there are subclinical deficits that would limit the participation of frailer older persons in the larger study. These measurements can be combined with others already being obtained in the PROMISS Study to create a profile of nutritional frailty.

3. Dual energy x-ray absorptiometry.

This test assesses body composition-primarily lean soft tissue and adipose tissue. The goal of this testing is to assess whether the participants have lost excessive lean mass relative to fat and whether performance of accelerometry differs by amount of lean mass and fat mass.

LEVEL OF EFFORT:

This requirement is for specific biomedical services estimated as follows, in terms of the tests per number of participants:

1. Medical Services for approximately 110 participants

2. Screening Laboratory Measures approximately 105

3. Dual Energy x-Ray Absorptiometry approximately 110

GOVERNMENT RESPONSIBILITIES

The government will monitor the study to assess the assumptions of nutritional frailty and whether this affects the relationship with accelerometry.

DELIVERY OR DELIVERABLES

Contractor will electronically deliver secure, de-identified final dataset including raw results and subsequent study eligibility determination due to medical screening, laboratory testing of nutrition, raw and processed dual energy absorptiometry variables, and accelerometry raw data from larger study to determine association of these measures with accelerometer measures.

REPORTING REQUIREMENTS

No written progress reports are necessary.

OTHER CONSIDERATIONS

Travel:

No contractor travel is required in the performance of the SOW.

Key Personnel:

A study coordinator, who already exists in the context of the study, is essential to the successful performance of the requirement. The study coordinator should have significant experience (graduate-level education; 3-5 years experience) in conducting clinical studies and directly conduct the testing or train and supervise the research staff. This PSC provides solely for the medical tests, not for personnel in the field.

Information System Security Plan:

The contractor will not be required to develop, access or host a federal information system.

Data Rights:

Data will be produced as a product of the statement of work. The government will share with the contractor the respective rights and obligations regarding the use, production, and disclosure of that data. However, only the government will have unlimited rights.

Section 508—Electronic and Information Technology Standards:

The contractor is not required to develop, procure, maintain, or use electronic information technology in the performance of the statement of work.

Publications and Publicity:

The government will analyze the acquired data and prepare publications based on the data in collaboration with the contractors.

Confidentiality of Information:

There are no anticipated issues of confidentiality.