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. 2018 May 8;19(1):271.
doi: 10.1186/s13063-018-2604-9.

iSupport, an online training and support program for caregivers of people with dementia: study protocol for a randomized controlled trial in India

Kala M Mehta  1 , Dolores Gallagher-Thompson  2 , Mathew Varghese  3 , Santosh Loganathan  3 , Upasana Baruah  3 , Katrin Seeher  4 , Diana Zandi  4 , Tarun Dua  4 , Anne Margriet Pot  4
Affiliations

iSupport, an online training and support program for caregivers of people with dementia: study protocol for a randomized controlled trial in India

Kala M Mehta et al. Trials. .

Abstract

Background: Dementia has a huge physical, psychological, social and economic impact upon caregivers, families and societies at large. There has been a growing impetus to utilize Internet interventions given the potential scalability, and presumed cost-effectiveness and accessibility. In this paper, we describe the design of a randomized controlled trial (RCT) aiming to study the impact of online self-help programs on caregivers of people with dementia in India. The experimental group will receive an interactive training and support program and the comparison group will receive an education-only e-book. It will be among the first online support intervention RCTs for a mental health condition in a lower-middle income country.

Methods and design: Two hundred and eight participants are expected to be recruited via several strategies (email, Internet and social media, telephone and face-to-face) starting in the Bangalore region of India. The inclusion criteria for participation in the trial are: (1) being 18 years or older, (2) being a self-reported caregiver of a person with dementia, (3) self-report that a family member has a diagnosis of dementia (AD8 ≥ 2), and experience caregiver distress (≥ 4 on a 1-item burden scale ranging from 1 to 10 or ≥ 4 or < 20 on the Center for Epidemiologic Study-Depression (CES-D) scale (10-item) or ≥ 4 or < 15 on the Generalized Anxiety Disorder Scale (7-item). The intervention group will be offered iSupport, an online self-help training and support program, enabling a personalized education plan with a maximum of 23 lessons. These modules present a range of topics from "what is dementia?" to "dealing with challenging behaviors like aggression." The comparison group will receive an education-only e-book containing similar content. The outcomes of this trial are: caregiver burden as measured by the 22-item Zarit Burden Scale, depressive symptoms, anxiety symptoms (primary outcomes), quality of life, person-centered attitude, self-efficacy and mastery (secondary outcomes).

Discussion: Based on the findings of this trial, we will examine the potential use and scale up of iSupport for caregiver distress in India. This style of online self-help programs could be expanded to other regions or countries or to other suitable caregiver groups.

Trial registration: Clinical Trials Registry-India (CTRI), ID: CTRI/2017/02/007876 .

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Conflict of interest statement

Authors’ information

* The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated.

For general inquiries regarding iSupport, please contact:

Anne Margriet Pot, PhD.

World Health Organization.

potam@who.int

For trial enrolment, please contact:

Dr. Mathew Varghese.

Geriatric Clinic and Services, NIMHANS, Hosur Road, Bangalore-560,029. Tel: 080–2699-5258, 080–2699-5269, + 91 9,480,829,468, 080–26,995,809, + 91 9,480,829,663.

URL:https://tinyurl.com/dementiacare4india

Registration details Clinical Trials Registry—India (CTRI) CTRI/2017/02/007876.

Protocol Date and version: 2 November 2017, version 1.0.

Ethics approval and consent to participate

The study was approved by the Medical Ethics Committees of the National Institute of Mental Health and Neurosciences (NIMHANS) and the World Health Organization (WHO). The trial was registered at the Clinical Trials Registry—India (CTRI), protocol # CTRI/2017/02/007876. Informed consent is part of the online support tool.

Competing interests

All authors (KM, DGT, MV, SL, UB, KS, DZ, TD and AMP) declare that they have no competing interests or financial disclosures.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of the iSupport Online Self-Help Program. T0 pre-measurement, T1 = first follow up 1–3 months post baseline, T2 second follow up: 2–6 months post T0
Fig. 2
Fig. 2
SPIRIT Flowchart of the iSupport online self-help program
Fig. 3
Fig. 3
iSupport: online self-help training and support program
See this image and copyright information in PMC

References

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