HEalthy Living in Inflammatory Arthritis (HELIA trial): a randomized controlled trial comparing efficacy between an interactive, online lifestyle intervention program and general nutrition recommendations

HEalthy Living in Inflammatory Arthritis (HELIA trial): a randomized controlled trial comparing efficacy between an interactive, online lifestyle intervention program and general nutrition recommendations - HELIA trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51687

Enrollment

200

Registered

2022-12-06

Start date

2023-03-03

Completion date

Unknown

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory arthritis

Interventions

See section study design

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in the study, a subject must meet all of the following criteria: - Diagnosed with rheumatoid arthritis(RA) or psoriatic arthritis(PsA), according to respectively the ACR/EULAR 2010 criteria for RA and CASPAR criteria - Low disease activity, defined as Disease Activity Score (DAS28)2.6 or Disease Activity in PSoriatic Arthritis(DAPSA) 5 - Stable DMARD dosage in the past six months - Age >=18 years;

Exclusion criteria

Exclusion criteria: - Unable to understand, speak and write in Dutch

Design outcomes

Primary

Measure	Time frame
The primary outcome is the proportional difference in DAS28/DAPSA remission and/or those who were able to taper their medication without having a disease flare after 12 months of follow-up between inflammatory arthritis patients who followed the lifestyle intervention program and those who received general nutrition recommendations. Disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients is respectively measured with the DAS28 and DAPSA. The DAS28 is a pooled index that involves the incorporation of an 28-joint count for tenderness (TJC28), a 28-joint count for swelling (SJC28), an erythrocyte sedimentation rate (ESR) and general health (GH, measured with a VAS 0 -100mm) into a formula to obtain a numerical indicator of disease activity. The DAS28 formula is 0.56(TJC28) + 0.28(SJC28) + 0.70ln(ESR) + 0.014(GH). The DAPSA is also a pooled index, which is made up following 5 domains: (1) a 68-joint count for tenderness, (2) a 66-joint count for swelling, (3) a C-reactive protein (expressed in mg/dl),(4) a patients assessment of the disease activity (VAS, 0 - 10 cm) and (5) a patients assessment of pain severity (VAS, 0 - 10 cm). The numerical values for the aforementioned 5 domains are summed to provide the DAPSA score. Thresholds for remission are respectively	—

Measure

Time frame

The primary outcome is the proportional difference in DAS28/DAPSA remission and/or those who were able to taper their medication without having a disease flare after 12 months of follow-up between inflammatory arthritis patients who followed the lifestyle intervention program and those who received general nutrition recommendations. Disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients is respectively measured with the DAS28 and DAPSA. The DAS28 is a pooled index that involves the incorporation of an 28-joint count for tenderness (TJC28), a 28-joint count for swelling (SJC28), an erythrocyte sedimentation rate (ESR) and general health (GH, measured with a VAS 0 -100mm) into a formula to obtain a numerical indicator of disease activity. The DAS28 formula is 0.56*(TJC28) + 0.28*(SJC28) + 0.70ln(ESR) + 0.014(GH). The DAPSA is also a pooled index, which is made up following 5 domains: (1) a 68-joint count for tenderness, (2) a 66-joint count for swelling, (3) a C-reactive protein (expressed in mg/dl),(4) a patient*s assessment of the disease activity (VAS, 0 - 10 cm) and (5) a patient*s assessment of pain severity (VAS, 0 - 10 cm). The numerical values for the aforementioned 5 domains are summed to provide the DAPSA score. Thresholds for remission are respectively

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Secondary

Measure	Time frame
For our secondary endpoints the effectiveness from a clinical, patient as well as a societal point of view, will be compared between the online interactive lifestyle intervention program and general nutrition recommendations. Clinical outcomes: • In rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients disease activity (states) are respectively measured with the DAS28 and DAPSA. The DAS28 is a pooled index that involves the incorporation of an 28-joint count for tenderness (TJC28), a 28-joint count for swelling (SJC28), an erythrocyte sedimentation rate (ESR) and general health (GH, measured with a VAS 0 -100mm) into a formula to obtain a numerical indicator of disease activity. The DAS28 formula is 0.56(TJC28) + 0.28(SJC28) + 0.70ln(ESR) + 0.014(GH). The DAPSA is also a pooled index, which is made up following 5 domains: (1) a 68-joint count for tenderness, (2) a 66-joint count for swelling, (3) a C-reactive protein (expressed in mg/dl), (4) a patients assessment of the disease activity (VAS, 0 - 10 cm) and (5) a patients assessment of pain severity (VAS, 0 - 10 cm). The numerical values for the aforementioned 5 domains are summed to provide the DAPSA score. Thresholds for remission and moderate-to-high disease activity are respectively =3.2 and >14. Patient reported outcomes (PROs): • Self-reported disease activity, measured with the Routine Assessment of Patient Index Data 3 (RAPID3). Thresholds for remission and moderate-to-high disease activity are respectively =6.1 if the 0 - 30 scale is used. • General Health, measured with a visual analogue scale (VAS, 0 - 100 mm), whereby higher scores reflect greater severity. • Pain, measured with a visual analogue scale (VAS, 0 - 100 mm), whereby higher scores reflect greater severity. • Morning stiffness (severity and duration), measured with a 10-point Likert scale, whereby higher scores reflect greater severity. • Fatigue, measured with the Functional Assessment of Chronic Il	—

Measure

Time frame

For our secondary endpoints the effectiveness from a clinical, patient as well as a societal point of view, will be compared between the online interactive lifestyle intervention program and general nutrition recommendations. Clinical outcomes: • In rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients disease activity (states) are respectively measured with the DAS28 and DAPSA. The DAS28 is a pooled index that involves the incorporation of an 28-joint count for tenderness (TJC28), a 28-joint count for swelling (SJC28), an erythrocyte sedimentation rate (ESR) and general health (GH, measured with a VAS 0 -100mm) into a formula to obtain a numerical indicator of disease activity. The DAS28 formula is 0.56*(TJC28) + 0.28*(SJC28) + 0.70ln(ESR) + 0.014(GH). The DAPSA is also a pooled index, which is made up following 5 domains: (1) a 68-joint count for tenderness, (2) a 66-joint count for swelling, (3) a C-reactive protein (expressed in mg/dl), (4) a patient*s assessment of the disease activity (VAS, 0 - 10 cm) and (5) a patient*s assessment of pain severity (VAS, 0 - 10 cm). The numerical values for the aforementioned 5 domains are summed to provide the DAPSA score. Thresholds for remission and moderate-to-high disease activity are respectively =3.2 and >14. Patient reported outcomes (PROs): • Self-reported disease activity, measured with the Routine Assessment of Patient Index Data 3 (RAPID3). Thresholds for remission and moderate-to-high disease activity are respectively =6.1 if the 0 - 30 scale is used. • General Health, measured with a visual analogue scale (VAS, 0 - 100 mm), whereby higher scores reflect greater severity. • Pain, measured with a visual analogue scale (VAS, 0 - 100 mm), whereby higher scores reflect greater severity. • Morning stiffness (severity and duration), measured with a 10-point Likert scale, whereby higher scores reflect greater severity. • Fatigue, measured with the Functional Assessment of Chronic Il

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)