Happy Hands E-self-management Pilot Study

NCT05150171 | Completed

• 1 other identifier: REK 249364
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot study will assess usability of a e-self-management program for patients with hand osteoarthritis through the Happy Hands app. People with hand osteoarthritis will be recruited for the study. The e-self-management intervention consists of informational videos and videos of hand exercises and has a duration of 12 weeks. Patient-reported outcomes and grip strength will be collected before and after the 12 week intervention period. Change in pain, stiffness, grip strength, disease activity and quality indicators will be assessed after 12 weeks.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in quality indicators for hand osteoarthritis treatment

  Quality indicators based on the OA-QI questionnaire, adopted to fit the treatment recommendations of hand osteoarthritis. 16 questions answered with yes, no or not appriopriate/do not know. Measured as pass rate.

  Baseline and 12 week follow-up

Secondary Outcomes (15)

• Pain intensity

  Baseline and 12 week follow-up

• Pain intensity

  After each exercise session (3 times a week for 12 weeks)

• Stiffness

  Baseline and 12 week follow-up

• Stiffness

  After each exercise session (3 times a week for 12 weeks)

• Grip strength

  Baseline and 12 week follow-up

Study Arms (1)

e-self-management intervention

EXPERIMENTAL

Patients will receive the HAPPY Hands e-self-management intervention delivered through a smartphone app.

Other: e-self-management intervention

Interventions

e-self-management intervention OTHER

The app is developed based on a combination of behavioural change techniques informed by Social cognitive theory and the EULAR recommendations on management of hand osteoarthritis. The 12-week intervention consists of 25 short informational videos addressing the themes prioritized by the patient research partners. Additionally, the intervention includes a hand exercise program consisting of 8 videos providing instructions on warm up, exercises to improve mobility, strength and coordination, and a stretching exercise. The informational videos and exercise program are delivered in a progressive order across the 12 weeks. Encouragement and motivational messages are provided each week to enhance continued adherence to the intervention.

e-self-management intervention

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Most women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed with hand osteoarthritis
• Possessing a smartphone

You may not qualify if:

• cognitive deficits
• are scheduled for hand surgery within the next 3 months
• if they do not talk or understand Norwegian,
• if they have uncontrolled serious comorbidities.

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• The Norwegian Rheumatism Association: collaborator

Study Sites (2)

Norwegian Rheumatology Association

Oslo, Please Select, 0130, Norway

Location

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

Related Publications (1)

• Tveter AT, Varsi C, Maarnes MK, Pedersen SJ, Christensen BS, Blanck TB, Nyheim SB, Pelle T, Kjeken I. Development of the Happy Hands Self-Management App for People with Hand Osteoarthritis: Feasibility Study. JMIR Form Res. 2024 Oct 29;8:e59016. doi: 10.2196/59016.

  PMID: 39470716 DERIVED

Study Officials

• Anne Therese Tveter, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: An e-self-management intervention consisting of videos informing patients with hand osteoarthritis about recommended treatment (information, hand exercises, use of assistive devices and orthoses, information about pharmacological and surgical treatment).

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 8, 2021
• Study Start: November 23, 2021
• Primary Completion: August 10, 2022
• Study Completion: December 31, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)