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Table 2 Outcome measures

From: Implementation and evaluation of an individualized physical exercise promotion program in people with manifested risk factors for multimorbidity (MultiPill-Exercise): a study protocol for a pragmatic randomized controlled trial

Characteristics & confounders Description and instrument Data source Sample Collection points
Overall
  Participant’s characteristics Date of birth, gender, ethnicity, BMI (height, weight), highest academic qualification (no degree, middle school, high school), labor situation (working, retired, unemployed in rehabilitation status), current profession, weight at birth, week of pregnancy at birth SAQ IG, CG t0
  Clinical status Diagnoses of OA, Diabetes mellitus Type 2, Cardio vascular disease, and if applicable, date of initial diagnosis, in case of OA site (s) and joint (s) of OA diagnosis SAQ, on-site CRF IG, CG t0
  Other diagnosed comorbidities SAQ, on-site CRF IG, CG t0
  Current medication assessed via medication schedule and/or packaging. Also, pre-determined drugs are recorded via the IDB SAQ
IDB
On-site CRF
IG, CG t0, t6, t12
  History of exercise participation Athleticism during childhood and adolescence SAQ IG, CG t0
  Outcome expectations Personal therapy expectations SAQ IG, CG t0
Primary Outcome measure Clinical Outcomes
  Physical activity status Leisure-time physical activity in a typical week (EHIS-PAQ, HEPA Index [38]) SAQ IG, CG t0, t3, t6, t12, t18
Secondary outcome measure Clinical outcomes
  Physical activity status Work-related and transport-related physical activity in a typical week (EHIS-PAQ [38]) SAQ IG; CG t0, t3, t6, t12, t18
Actigraph (wGT3X-BT Accelerometer) for 7 days wGT3X-BT Accelerometer IG, CG t0, t6, t12
  Health related quality of life Veterans RAND 12 Item Health Survey (VR12), retrospective 4 weeks [39, 40] SAQ IG, CG t0, t3, t6, t12, t18
  Global health assessment One Item, General Health, of the VR12 [39, 40] to assess global health [41] SAQ IG, CG t0, t3, t6, t12, t18
  Overall perceived benefit Overall perceived satisfaction with the benefit of the intervention [42] SAQ IG, CG t3, t6, t12, t18
  Osteoarthritis specific outcomes Hip Osteoarthritis Outcome Score (HOOS), Knee injury and Osteoarthritis Outcome Score (KOOS) SAQ IG, CG (only participants with OA) t0, t3, t6, t12, t18
Pain visual analog pain scale (0–10) [42, 43] SAQ IG, CG (only participants with OA) t0, t3, t6, t12, t18
  Cardio vascular risk status 10-year risk of myocardial infarction, PROCAM-Score short form [32] SAQ IG, CG t0, t3, t6, t12, t18
  Diabetes mellitus risk status German diabetes risk score [30, 31] SAQ IG, CG t0, t3, t6, t12, t18
  Dietary intake Food Frequency Questionnaire [44] SAQ IG, CG t0, t3, t6, t12, t18
  Physiological Outcomes
  Physical performance measures Spiroergometry: VO2 max, respiratory ratio, physical working capacity (Aeroscan GmbH) Aeroman IG, CG t0, t6, t12
Lower body strength measure: 30 s sit to stand Test (CST) [42, 45] 30 CST IG; CG t0, t6, t12
Electrocardiogram (ECG) (custo med GmbH) to assess heart rate, systolic and diastolic blood pressure at rest and during exercise test Custo Cardio 300 IG; CG t0, t6, t12
  Body composition Assessment of body composition (muscle, fat, water distribution) with bioimpedance analysis (SMT medical GmbH & Co.) BIA101 BIVA IG, CG t0, t6, t12
  Metabolomics Capillary blood sample from earlobes on Guthrie cards to assess carnitine, short- and long-chain acylcarnitines, methionine, phenylalanine, tyrosine, valine, leucine, isoleucine, succinylacetone, citrulline Blood sample IG, CG t0, t6, t12
  Laboratory data Fasting blood sample: HbA1c, insulin, fasting glucose, IL-6, CRP, cholesterol, LDL, HDL, triglycerides, miRNAs, adiponectin, leptin, resistin, COMP Urine sample: CTXII Blood and Urine sample Sub-sample IG, CG t0, t6, t12
  Exercise psychological outcomes
  Exercise-specific self-efficacy Multidimensional Self-Efficacy for Exercise Scale: task, coping, and scheduling efficacy [46] SAQ IG, CG t0, t3, t6, t12, t18
  Sport and exercise-related self-concordance Self-concordance of sport- and exercise-related goals: intrinsic, identified, introjected, and extrinsic modes of motivation [47] SAQ IG, CG t0, t3, t6, t12, t18
  Physical-activity related health competence Physical-activity related health competence questionnaire: control of physical load, affect regulation, and self-control [21, 48] SAQ IG, CG t0, t3, t6, t12, t18
  Sport- and exercise specific motivational competence Questionnaire on
motivational competence in exercise and sport: knowing one’s own preferences, knowing what to expect in different exercise and sport activities and choosing and arranging an exercise and sport activity [49]
SAQ IG, CG t0, t3, t6, t12, t18
  Action and coping planning Exercise planning scales: action plans, coping plans [50] SAQ IG, CG t0, t3, t6, t12, t18
  Attitudes towards physical activity Cognitive and affective attitudes towards physical activity [51] SAQ IG, CG t0, t3, t6, t12, t18
  Motives and goals for exercise Bernese motive and goal inventory [52] SAQ IG Throughout intervention phase 1 (week 7), t6, t12
  Fear of movement
/(re)injury
Tampa Scale for Kinesiophobia [53] SAQ IG, CG t0, t3, t6, t12, t18
  Economic Data
  Unspecific and specific (disease-related) health care costs Outpatient costs, hospital costs, medication, adjuvants, rehabilitation treatment, medically prescribed supplementary treatments (e.g. hydrotherapy, physiotherapy, massages) IDB IG, CG tm18, tm12, tm6
t6, t12, t18
  Unspecific/specific (disease related) periods of disability Days of disability (overall and related to referred diseases) IDB IG, CG tm18, tm12, tm6
t6, t12, t18
  Intervention related costs Costs for human and physical resources/session IDB IG t6, t18
  Process evaluation
  Characteristics of the usual care arm Questions on utilization of usual care offers SAQ CG t3, t6, t12
  Participants’ satisfaction Modified version of the ZUF-8 Questionnaire to assess participants’ satisfaction with the intervention [54] SAQ IG, CG t3, t6, t12, t18
  Participants’ view on the intervention Qualitative interviews with participants including questions on the appropriateness and quality of the intervention delivery QI Sub-sample IG after last intervention delivery
  Treatment fidelity Field notes for intervention progress (Troubleshooting) Documentation sheets Research Team continuously
  Notes for intervention delivery Notation sheets Interventionists continuously
  Characteristics of interventionists Questionnaires on occupational self-efficacy [55], subjective value attributions [56] and implementation outcomes (acceptability, appropriateness, and feasibility of the intervention) [57] SAQ Interventionists t0, t6
  Interventionists’ view on the program Qualitative interviews with exercise specialists regarding acceptability, practicality, appropriateness and fidelity aspects of the intervention delivery QI Interventionists after last intervention delivery
  Satisfaction with the interventionists’ training [58] SAQ Interventionists after interventionists training
  Evaluation of implementation regarding interfaces of the health service innovation Practitioners’ view on the acceptability, appropriateness, and feasibility of the program and its prescription [57] SAQ Health insurance company (APS) during recruitment
  Mode of access to the program Telephone screening IG, CG during recruitment
  Evaluation of implementation regarding the interface with community-based exercise offers Qualitative interviews with participants and employees of the health insurance company QI Sub-sample IG and interventionists after last intervention delivery
  Adherence to exercise training Summarized number of attended training sessions and reported trainings sessions according to training logs of the exercise specialists and participants (IG) Training logs, on-site reporting sheet (IG);
SAQ, IDB (for CG only)
IG, CG t3, t6
  Safety and Adverse Events
  Adverse events and side-effects Summarized number and details of adverse events and side-effects according to training log and case report form Training logs, on-site CRF, SAQ IG t3, t6
Covariates
  Depressive and anxiety symptoms Self-report of depressive symptoms and anxiety symptoms in the last week [59] SAQ IG, CG t0, t3, t6, t12, t18
  Osteoporosis risk status German version of osteoporosis risk test [60] SAQ IG, CG t0, t3, t6, t12, t18
  Back pain Three months retrospective questionnaire on the severity of chronic back pain [61, 62] SAQ IG, CG t0, t3, t6, t12, t18
  1. APS Physician-Partner-Service, CG Control group (regular care), CRF Case report form (on-site CRF will be provided by study staff, exercise specialists and physician, if applicable; eCRF Electronic case report form), ECG Electrocardiogram, HEPA Index Health enhancing physical activity, IDB Insurance data base, IG Intervention Group MultiPill-Exercise, PE Physical exercise, SAQ Self-administered (online) questionnaire, t Collections points, m Minus. 0, 3, 6, 12, 24: month of collection point related to baseline (t0), QI Qualitative interview