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Implementation of ProMuscle in Daily Practice (PUMP-fit)

Primary Purpose

Sarcopenia, Frailty, Aging Problems

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PUMP-fit strategy (implementation toolbox)
Implementation as usual
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring implementation, lifestyle intervention, prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

To be eligible to participate in this study, healthcare professionals must met the following criteria: Physical therapist, lifestyle coach or dietician in one of the communities in the Foodvalley in the Netherlands Interested in combined lifestyle programs for older adults Frequently involved in maintaining physical functioning in older adults In and exclusion criteria for older residents receiving ProMuscle are: Inclusion criteria: Aged 65 years or older Living in one of the eight communities of the 'Foodvalley' (Ede, Wageningen, Nijkerk, Rhenen, Veenendaal, Barneveld, Scherpenzeel, Renswoude) Able to understand Dutch Are pre-frail or frail (score 1 or more points on the Fried frailty criteria), or report loss of muscle strength Exclusion criteria: - One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner

Sites / Locations

  • University Medical Center UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Implementation as usual

PUMP-fit strategy: Implementation toolbox

Arm Description

Healthcare professionals will be instructed to implement ProMuscle in their practice as usual

Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation

Outcomes

Primary Outcome Measures

Adoption of ProMuscle
The number of healthcare professionals delivering ProMuscle is measured with administrative data and the REport of Sustainment Scale (PRESS). Because it is not possible to measure adoption at baseline, The Measure of Innovation-Specific Implementation Intentions (MISII) questionnaire will be used to measure adoptability (the attention to adopt an EBP) at T0
Fidelity of ProMuscle
Fidelity is the degree to which an intervention was implemented as prescribed. The number of activities described in the ProMuscle guideline executed by the healthcare professionals will be assessed with a self-report checklist based on the content of the ProMuscle intervention. Comparing the outcomes of fidelity before and after receiving the PUMP-fit strategy can indicate whether the toolbox contributed to the fidelity of delivery of ProMuscle.

Secondary Outcome Measures

Fidelity of the PUMP-fit strategy
Fidelity is the degree to which an intervention was implemented as prescribed. For the PUMP-fit strategy, fidelity is defined as the degree to which the activities described in the online implementation toolbox are implemented as prescribed. The number of implementation activities described in the implementation toolbox and the time healthcare professionals are active in the implementation toolbox will be collected from the online platform (tracking activity). Fidelity according to healthcare professionals will be assessed with a self-report containing statements based on the Fidelity of Implementation (FOI) framework. The statements are scored with a 5-point Likert scale, the higher the score, the higher the fidelity. In addition, the experience of healthcare professionals about the fidelity will be investigated during the process evaluation guided by the domain "implementation" of the RE-AIM framework.
Acceptability of the PUMP-fit strategy
Acceptability will be measured with the translated Acceptability of Intervention Measure (AIM). The AIM contains four statements about the acceptability of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the acceptability of the PUMP-fit strategy.
Appropriateness of the PUMP-fit strategy
Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM). The IAM contains four statements about the appropriateness of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the appropriateness of the PUMP-fit strategy.
Feasibility of the PUMP-fit strategy
Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire. The FIM contains four statements about the feasibility of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the feasibility of the PUMP-fit strategy.
Barriers and facilitators for implementation of ProMuscle
Barriers and facilitators will be assessed with a questionnaire developed by the research group. The questionnaire contains statements about different factors that could influence implementation (CFIR framework) and is based on the 'Wandersman readiness thinking tool' and 'Organization Readiness'. Statements are rated on a 5-point Likert scale. Factors that are scored three or lower will be defined as barriers. Factors that are scored with four of higher will be defined as facilitators. Moreover, during the washout period and process evaluation barriers and facilitators will be identified in interviews with healthcare professionals implementing ProMuscle.
Acceptability of ProMuscle
Acceptability of ProMuscle will be measured with the translated Acceptability of Intervention Measure (AIM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale. The higher the score, the higher the score the higher the acceptability of the ProMuscle intervention
Appropriateness of ProMuscle
Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score the higher the appropriateness of ProMuscle.
Feasibility of ProMuscle
Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score, the higher the score the higher the feasibility of the ProMuscle intervention
Reach of ProMuscle
Reach is defined as the number of older adults and will be measured by administrative data.
Sustainment of ProMuscle
Sustainment of the implementation of ProMuscle will be measured with the Program Sustainability Assessment Tool (PSAT) and during a one-hour focus group guided by the RE-AIM framework (domain Maintenance) to assess if ProMuscle became part of daily care.
Physical functioning recipients of ProMuscle
The Short Physical Performance Battery (SPPB) is conducted by participating healthcare professionals to asses physical functioning.
Functional lower extremity strength recipients of ProMuscle
Repeated chair-rise test is conducted by participating healthcare professionals to assess functional strength.
Leg strength recipients of ProMuscle
The one repetition (1RM) of leg strength is performed on leg press machines. The 1RM is conducted by participating healthcare professionals. The 1RM measures the maximal strength and can be used to develop the exercise program.
Functional mobility recipients of ProMuscle 1RM
Functional mobility is measured with the Timed-Up-And-Go test (TUG).
Care dependency recipients of ProMuscle
Healthcare professionals report the current health status of the recipients in terms of care dependency. Recipients are asked if they receive care. Answers can be categorized as no care, care from spouse or family, domestic worker, home care, nursing or other help.
Lean body mass recipients ProMuscle
Lean body mass is measured with the bioelectrical impedance analysis (BIA)

Full Information

First Posted
December 19, 2022
Last Updated
January 2, 2023
Sponsor
UMC Utrecht
Collaborators
Regiodeal Foodvalley
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1. Study Identification

Unique Protocol Identification Number
NCT05672004
Brief Title
Implementation of ProMuscle in Daily Practice
Acronym
PUMP-fit
Official Title
Implementation of the Combined Lifestyle Intervention ProMuscle for Community-living Older Adults in Community-care Practices.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Regiodeal Foodvalley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Implementation of a previously shown (cost-)effective combined lifestyle intervention for community living older adults, ProMuscle, in at least four of the eight communities of the 'Foodvalley' in the Netherlands.
Detailed Description
ProMuscle is a combined lifestyle intervention that has been shown effective in improving muscle mass, muscle strength, and physical functioning in community-dwelling older adults. Potentially, it could facilitate older people in maintaining their functional independence. Despite the promising results, ProMuscle is still not part of daily care. Previously factors influencing successful implementation were identified and implementation strategies targeting these factors were developed and formatted as an implementation toolbox for healthcare professionals. To increase the likelihood of successful implementation of ProMuscle, this study aims to investigate the PUMP-fit strategy (implementation toolbox) effectiveness on the adoption of ProMuscle in community-care A hybrid type 3 stepped wedge cluster trial with a mixed method analysis will be conducted to assess the effectiveness of the PUMP-fit implementation toolbox. A stepped wedge trail is chosen because of the ability to compare between clusters, but also within clusters. Moreover, ProMuscle is already found effective, and the researchers hypothesized that the implementation toolbox should be assessable for all healthcare professionals in the 'Foodvalley'. At last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect. In addition, the researchers hypothesized that the program would be adapted to specific contexts' outcomes from the recipients of ProMuscle will be collected. A hybrid type three trial aims to investigate the implementation as a primary outcome and the effect of the (adapted) intervention as a secondary outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Frailty, Aging Problems
Keywords
implementation, lifestyle intervention, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
stepped wedge cluster trial and mixed methods process analysis
Masking
None (Open Label)
Masking Description
Recipients of ProMuscle are not the target group within this study. Healthcare professionals are the participants of the study, they know that they received the implementation toolbox once they switched to the intervention group
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implementation as usual
Arm Type
Active Comparator
Arm Description
Healthcare professionals will be instructed to implement ProMuscle in their practice as usual
Arm Title
PUMP-fit strategy: Implementation toolbox
Arm Type
Experimental
Arm Description
Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation
Intervention Type
Other
Intervention Name(s)
PUMP-fit strategy (implementation toolbox)
Intervention Description
Healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting (during the control period). Healthcare professionals will be informed about the platform and toolbox. Healthcare professionals receive a personal log-in for the online platform. Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible on the platform Within the separate environment of the online platform, healthcare professionals can access their implementation toolbox. The toolbox is tailored to their personal context based on the results of the 'Readinesstool'.
Intervention Type
Other
Intervention Name(s)
Implementation as usual
Intervention Description
First, healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting. At the end of the training healthcare professionals are informed about the mandatory conditions to implement ProMuscle (champion, material, approval of management). Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible. Results contain a graph of possible barriers for implementation in their practice. Hereafter they will be instructed to start with implementation as usual.
Primary Outcome Measure Information:
Title
Adoption of ProMuscle
Description
The number of healthcare professionals delivering ProMuscle is measured with administrative data and the REport of Sustainment Scale (PRESS). Because it is not possible to measure adoption at baseline, The Measure of Innovation-Specific Implementation Intentions (MISII) questionnaire will be used to measure adoptability (the attention to adopt an EBP) at T0
Time Frame
36 weeks
Title
Fidelity of ProMuscle
Description
Fidelity is the degree to which an intervention was implemented as prescribed. The number of activities described in the ProMuscle guideline executed by the healthcare professionals will be assessed with a self-report checklist based on the content of the ProMuscle intervention. Comparing the outcomes of fidelity before and after receiving the PUMP-fit strategy can indicate whether the toolbox contributed to the fidelity of delivery of ProMuscle.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Fidelity of the PUMP-fit strategy
Description
Fidelity is the degree to which an intervention was implemented as prescribed. For the PUMP-fit strategy, fidelity is defined as the degree to which the activities described in the online implementation toolbox are implemented as prescribed. The number of implementation activities described in the implementation toolbox and the time healthcare professionals are active in the implementation toolbox will be collected from the online platform (tracking activity). Fidelity according to healthcare professionals will be assessed with a self-report containing statements based on the Fidelity of Implementation (FOI) framework. The statements are scored with a 5-point Likert scale, the higher the score, the higher the fidelity. In addition, the experience of healthcare professionals about the fidelity will be investigated during the process evaluation guided by the domain "implementation" of the RE-AIM framework.
Time Frame
24 weeks
Title
Acceptability of the PUMP-fit strategy
Description
Acceptability will be measured with the translated Acceptability of Intervention Measure (AIM). The AIM contains four statements about the acceptability of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the acceptability of the PUMP-fit strategy.
Time Frame
36 weeks
Title
Appropriateness of the PUMP-fit strategy
Description
Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM). The IAM contains four statements about the appropriateness of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the appropriateness of the PUMP-fit strategy.
Time Frame
36 weeks
Title
Feasibility of the PUMP-fit strategy
Description
Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire. The FIM contains four statements about the feasibility of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the feasibility of the PUMP-fit strategy.
Time Frame
36 weeks
Title
Barriers and facilitators for implementation of ProMuscle
Description
Barriers and facilitators will be assessed with a questionnaire developed by the research group. The questionnaire contains statements about different factors that could influence implementation (CFIR framework) and is based on the 'Wandersman readiness thinking tool' and 'Organization Readiness'. Statements are rated on a 5-point Likert scale. Factors that are scored three or lower will be defined as barriers. Factors that are scored with four of higher will be defined as facilitators. Moreover, during the washout period and process evaluation barriers and facilitators will be identified in interviews with healthcare professionals implementing ProMuscle.
Time Frame
36 weeks
Title
Acceptability of ProMuscle
Description
Acceptability of ProMuscle will be measured with the translated Acceptability of Intervention Measure (AIM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale. The higher the score, the higher the score the higher the acceptability of the ProMuscle intervention
Time Frame
36 weeks
Title
Appropriateness of ProMuscle
Description
Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score the higher the appropriateness of ProMuscle.
Time Frame
36 weeks
Title
Feasibility of ProMuscle
Description
Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score, the higher the score the higher the feasibility of the ProMuscle intervention
Time Frame
36 weeks
Title
Reach of ProMuscle
Description
Reach is defined as the number of older adults and will be measured by administrative data.
Time Frame
36 weeks
Title
Sustainment of ProMuscle
Description
Sustainment of the implementation of ProMuscle will be measured with the Program Sustainability Assessment Tool (PSAT) and during a one-hour focus group guided by the RE-AIM framework (domain Maintenance) to assess if ProMuscle became part of daily care.
Time Frame
54 weeks
Title
Physical functioning recipients of ProMuscle
Description
The Short Physical Performance Battery (SPPB) is conducted by participating healthcare professionals to asses physical functioning.
Time Frame
54 weeks
Title
Functional lower extremity strength recipients of ProMuscle
Description
Repeated chair-rise test is conducted by participating healthcare professionals to assess functional strength.
Time Frame
54 weeks
Title
Leg strength recipients of ProMuscle
Description
The one repetition (1RM) of leg strength is performed on leg press machines. The 1RM is conducted by participating healthcare professionals. The 1RM measures the maximal strength and can be used to develop the exercise program.
Time Frame
54 weeks
Title
Functional mobility recipients of ProMuscle 1RM
Description
Functional mobility is measured with the Timed-Up-And-Go test (TUG).
Time Frame
54 weeks
Title
Care dependency recipients of ProMuscle
Description
Healthcare professionals report the current health status of the recipients in terms of care dependency. Recipients are asked if they receive care. Answers can be categorized as no care, care from spouse or family, domestic worker, home care, nursing or other help.
Time Frame
54 weeks
Title
Lean body mass recipients ProMuscle
Description
Lean body mass is measured with the bioelectrical impedance analysis (BIA)
Time Frame
54 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
To be eligible to participate in this study, healthcare professionals must met the following criteria: Physical therapist, lifestyle coach or dietician in one of the communities in the Foodvalley in the Netherlands Interested in combined lifestyle programs for older adults Frequently involved in maintaining physical functioning in older adults In and exclusion criteria for older residents receiving ProMuscle are: Inclusion criteria: Aged 65 years or older Living in one of the eight communities of the 'Foodvalley' (Ede, Wageningen, Nijkerk, Rhenen, Veenendaal, Barneveld, Scherpenzeel, Renswoude) Able to understand Dutch Are pre-frail or frail (score 1 or more points on the Fried frailty criteria), or report loss of muscle strength Exclusion criteria: - One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia J van der Laag, MSc
Phone
003161118181
Email
p.j.vanderlaag-3@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette Schoonhoven, prof
Organizational Affiliation
Julius Center, University Medical Center Utrecht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia J van der Laag, MSc
Phone
+3161118181
Email
p.j.vanderlaag-3@umcutrecht.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementation of ProMuscle in Daily Practice

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