Implementation of ProMuscle in Daily Practice
- Conditions
- FrailtySarcopeniaAging Problems
- Interventions
- Other: PUMP-fit strategy (implementation toolbox)Other: Implementation as usual
- Registration Number
- NCT05672004
- Lead Sponsor
- UMC Utrecht
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PUMP-fit strategy: Implementation toolbox PUMP-fit strategy (implementation toolbox) Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation Implementation as usual Implementation as usual Healthcare professionals will be instructed to implement ProMuscle in their practice as usual
- Primary Outcome Measures
Name Time Method Adoption of ProMuscle 36 weeks 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 36 weeks 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
Name Time Method Appropriateness of the PUMP-fit strategy 36 weeks 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.
Appropriateness of ProMuscle 36 weeks 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 36 weeks 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 36 weeks Reach is defined as the number of older adults and will be measured by administrative data.
Functional mobility recipients of ProMuscle 1RM 54 weeks Functional mobility is measured with the Timed-Up-And-Go test (TUG).
Lean body mass recipients ProMuscle 54 weeks Lean body mass is measured with the bioelectrical impedance analysis (BIA)
Barriers and facilitators for implementation of ProMuscle 36 weeks 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 36 weeks 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
Functional lower extremity strength recipients of ProMuscle 54 weeks Repeated chair-rise test is conducted by participating healthcare professionals to assess functional strength.
Leg strength recipients of ProMuscle 54 weeks 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.Fidelity of the PUMP-fit strategy 24 weeks 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 36 weeks 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.
Feasibility of the PUMP-fit strategy 36 weeks 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.
Sustainment of ProMuscle 54 weeks 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 54 weeks The Short Physical Performance Battery (SPPB) is conducted by participating healthcare professionals to asses physical functioning.
Care dependency recipients of ProMuscle 54 weeks 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.
Trial Locations
- Locations (1)
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands